Material, Tooth Shade, Resin
FDA product code EBF · Class II (moderate risk) · 21 CFR 872.3690 · Dental
936510(k) clearances
0PMA approvals
71recalls
Manufacturers
- Voco GmbH 45
- Bisco, Inc. 30
- Pulpdent Corp. 29
- Scientific Pharmaceuticals, Inc. 29
- Dentsply Intl. 28
- Ivoclar North America, Inc. 28
- Sybron Dental Specialties, Inc. 28
- Shofu Dental Corp. 27
- GC America, Inc. 24
- Kulzer, Inc. 19
- Kuraray Co. 18
- Kuraray Medical, Inc. 18
- 3M Company 18
- Heraeus Kulzer, Inc. 18
- Ivoclar Vivadent, Inc. 17
- Ultradent Products, Inc. 17
- Johnson & Johnson Professionals, Inc. 15
- Jeneric/Pentron, Inc. 15
- Espe GmbH (Us) 13
- Cosmedent, Inc. 12
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | Ultradent Products, Inc. | 07/01/2026SE |
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | Ivoclar Vivadent, Inc. | 07/01/2026SE |
| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)EBF · Traditional | Mmtech Projetos Tecnologicos Importacao E… | 04/23/2026SE |
| K260661 | Midas RestoreEBF · Traditional | Sprintray, Inc. | 04/15/2026SE |
| K253036 | Light-curing Coloring Materials (ALCM)EBF · Traditional | Aidite (Qinhuangdao) Technology Co., Ltd. | 04/06/2026SE |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF · Traditional | Kulzer, LLC | 03/11/2026SE |
| K254245 | Zafira®EBF · Traditional | New Stetic, SA | 03/03/2026SE |
| K260170 | LumiCeraEBF · Traditional | Hangzhou SHINING3D Dental Technology Co., Ltd. | 01/21/2026SE |
| K252465 | Any-CoreEBF · Traditional | Mediclus Co., Ltd. | 12/05/2025SE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial CompositeEBF · Traditional | Premier Dental Products Company | 11/07/2025SE |
| K253236 | G-BlockEBF · Abbreviated | Graphenano Dental S.L. | 09/29/2025SE |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)EBF · Traditional | Hangzhou SHINING3D Dental Technology Co., Ltd. | 09/23/2025SE |
| K251946 | G aenial Universal Injectable IIEBF · Traditional | GC America, Inc. | 08/29/2025SE |
| K251283 | Once-Fil FlowEBF · Traditional | Mediclus Co., Ltd. | 06/06/2025SE |
| K250317 | EsFlow PLUSEBF · Traditional | Spident Co., Ltd. | 05/30/2025SE |
| K251578 | Beautifil IIEBF · Traditional | Shofu Dental Corporation | 05/27/2025SE |
| K250778 | Sil-FlowEBF · Traditional | Dsi Dental Solutions, Ltd. | 05/23/2025SE |
| K251239 | GrandioSO UnlimitedEBF · Special | Voco GmbH | 05/21/2025SE |
| K250763 | ReonEBF · Traditional | C.E.I.B.Med | 05/12/2025SE |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge ResinEBF · Traditional | Aidite (Qinhuangdao) Technology Co., Ltd. | 04/30/2025SE |
| K250823 | Any-Com FlowEBF · Special | Mediclus Co., Ltd. | 04/14/2025SE |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…EBF · Traditional | Kettenbach GmbH & Co. KG | 03/14/2025SE |
| K242713 | Any-Com BulkEBF · Traditional | Mediclus Co., Ltd. | 02/07/2025SE |
| K242572 | TopCEM-Try in Veneer Try-in GelEBF · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K243720 | 3Delta UNlimitedEBF · Traditional | Deltamed GmbH | 12/18/2024SE |
| K242816 | QuantiumEBF · Traditional | Bisco, Inc. | 12/17/2024SE |
| K233273 | C&B Ceramic; C&B Permanent; C&B InterimEBF · Traditional | Prevest Denpro Limited | 11/27/2024SE |
| K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir…EBF · Traditional | Edelweiss Dentistry Products GmbH | 10/18/2024SE |
| K232994 | Vittra APS Unique FlowEBF · Traditional | Dentscare Ltda | 10/18/2024SE |
| K242097 | DenMat Bulk Fill CompositeEBF · Traditional | Den-Mat Holdings, LLC | 10/15/2024SE |
| K241673 | Denture Base Resin (PN-Denture (Red, White))EBF · Traditional | Shenzhen Piocreat 3D Technology Co., Ltd. | 10/15/2024SE |
| K242014 | Jet Flow BulkEBF · Traditional | Meta Biomed Co., Ltd. | 10/08/2024SE |
| K242277 | Crown HTEBF · Traditional | Sprintray, Inc. | 10/01/2024SE |
| K241147 | Any-ComEBF · Traditional | Mediclus Co., Ltd. | 09/26/2024SE |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…EBF · Traditional | Kulzer, LLC | 09/17/2024SE |
| K232559 | C&B NFH HybridEBF · Traditional | Arum Dentistry Co., Ltd. | 09/11/2024SE |
| K240823 | els extra low shrinkage® composite & els extra low shrinkage® flowEBF · Abbreviated | Saremco Dental AG | 06/27/2024SE |
| K231142 | Temporis, Irix PlusEBF · Traditional | Dws S.R.L. | 04/25/2024SE |
| K240694 | FORMA Composite (Shade A3D)EBF · Traditional | Ultradent Products, Inc. | 03/15/2024SE |
| K240112 | Light Cure CompositeEBF · Traditional | Sincera Technology (Changchun) Co., Ltd. | 03/15/2024SE |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTEBF · Traditional | Prevest Denpro Limited | 01/05/2024SE |
| K233082 | TopCEM Dual Cure Resin CementEBF · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/22/2023SE |
| K232050 | saremco print BRIDGETECEBF · Abbreviated | Saremco Dental AG | 11/14/2023SE |
| K233596 | VarseoSmile TriniQEBF · Traditional | Bego Bremer Goldschlägerei Wilh. Herbst GmbH &… | 11/09/2023SE |
| K233502 | Tera Harz IIEBF · Traditional | Graphy, Inc. | 11/01/2023SE |
| K230644 | Signum opaque FEBF · Traditional | Kulzer, LLC | 09/07/2023SE |
| K231523 | EsCom250EBF · Traditional | Spident Co., Ltd. | 07/24/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | Voco GmbH | 07/13/2023SE |
| K223742 | Dental Ceramic BlocksEBF · Traditional | Aidite (Qinhuangdao) Technology Co., Ltd. | 03/08/2023SE |
| K222445 | LC ChromeFlowEBF · Traditional | S&C Polymer Silicon- Und Composite Spezialitaten… | 03/06/2023SE |
| K222623 | Digital CrownEBF · Traditional | Sprintray, Inc. | 12/14/2022SE |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative CompositeEBF · Traditional | Premier Dental Products Company | 12/06/2022SE |
| K222583 | Stela Capsule SystemEBF · Traditional | Sdi Limited | 10/28/2022SE |
| K222581 | Stela Automix SystemEBF · Traditional | Sdi Limited | 10/28/2022SE |
| K221510 | TrusFIL-Flow Flowable Composite RestorativeEBF · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 10/12/2022SE |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF · Traditional | Cosmedent, Inc. | 10/11/2022SE |
| K222877 | FREEPRINT crownEBF · Traditional | Detax GmbH | 09/23/2022SE |
| K213339 | DENU Composite Resin, DENU Flow ResinEBF · Abbreviated | Hdi, Inc. | 09/23/2022SE |
| K222723 | AMBARINO High-ClassEBF · Traditional | Creamed GmbH & Co. Produktions- Und Handels KG | 09/09/2022SE |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowEBF · Traditional | Kerr Corporation | 08/31/2022SE |
| K220329 | G-CamEBF · Abbreviated | Graphenano Dental S.L. | 08/16/2022SE |
| K220077 | IMICRYL Composite, Composite Flow MaterialsEBF · Traditional | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 08/09/2022SE |
| K221909 | J-TempEBF · Traditional | Ultradent Products, Inc. | 07/01/2022SE |
| K221695 | 3M Filtek Supreme Flowable RestorativeEBF · Traditional | 3M Company Espe Dental Products | 06/13/2022SE |
| K202920 | OptiCompEBF · Traditional | Pac-Dent, Inc. | 05/25/2022SE |
| K220605 | Venus Bulk Flow ONEEBF · Special | Kulzer, LLC | 04/21/2022SE |
| K213343 | Saremco Print CROWNTECEBF · Abbreviated | Saremco Dental AG | 01/21/2022SE |
| K211804 | 3Delta CrownEBF · Traditional | Deltamed GmbH | 12/06/2021SE |
| K211345 | C-30 Crown KitEBF · Traditional | Perfect Fit Crowns, LLC | 11/24/2021SE |
| K210231 | Vittra APS UniqueEBF · Traditional | Dentscare Ltda | 10/14/2021SE |
| K202063 | TrusFIL Universal Composite RestorativeEBF · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 10/06/2021SE |
| K210045 | Activa Presto PackEBF · Traditional | Pulpdent Corporation | 09/22/2021SE |
| K210412 | Pac-Dent Ceramic Nanohybrid ResinEBF · Traditional | Pac-Dent, Inc. | 07/26/2021SE |
| K210349 | TKO Composite Bite Turbo GelEBF · Traditional | Reliance Orthodontic Products, Inc. | 07/20/2021SE |
| K202846 | Tera HarzEBF · Traditional | Graphy, Inc. | 07/15/2021SE |
| K210421 | Diafil & Diafil CapsuleEBF · Special | DiaDent Group International | 06/28/2021SE |
| K211259 | Renamel BulkfillEBF · Traditional | Cosmedent, Inc. | 06/24/2021SE |
| K210977 | E-Dent 1000EBF · Traditional | Envisiontec GmbH | 05/25/2021SE |
| K200470 | Shofu Block HC HardEBF · Traditional | Shofu Dental Corporation | 02/05/2021SE |
| K203598 | Omnichroma Flow BulkEBF · Traditional | Tokuyama Dental Corporation | 02/03/2021SE |
| K201707 | Opallis, Opallis FlowEBF · Traditional | Dentscare Ltda | 12/22/2020SE |
| K200155 | Bright High FlowEBF · Traditional | Genoss Co., Ltd. | 11/30/2020SE |
| K200156 | Bright Low FlowEBF · Traditional | Genoss Co., Ltd. | 10/27/2020SE |
| K201795 | TranscendEBF · Abbreviated | Ultradent Product, Inc. | 09/28/2020SE |
| K193537 | Omnichroma FlowEBF · Traditional | Tokuyama Dental Corporation | 08/19/2020SE |
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow CompositeEBF · Traditional | Nobio , Ltd. | 08/14/2020SE |
| K201307 | VisCalorEBF · Special | Voco GmbH | 07/08/2020SE |
| K201668 | VarseoSmile Crown plusEBF · Traditional | Bego Bremer Goldschlägerei Wilh. Herbst GmbH &… | 06/23/2020SE |
| K193496 | CharmFilEBF · Traditional | Dentkist, Inc. | 05/06/2020SE |
| K190139 | Zircos-ComEBF · Traditional | Bioden Co., Ltd. | 04/24/2020SE |
| K200294 | GrandioSO Light FlowEBF · Special | Voco GmbH | 03/27/2020SE |
| K192284 | DiaFil FlowEBF · Traditional | DiaDent Group International | 03/25/2020SE |
| K192510 | DIAFIL & DIAFIL CapsuleEBF · Traditional | DiaDent Group International | 03/20/2020SE |
| K191991 | EzfilEBF · Traditional | Meta Biomed Co., Ltd. | 03/05/2020SE |
| K191389 | Allcem Veneer APSEBF · Traditional | Dentscare Ltda | 02/25/2020SE |
| K192178 | R&D Series Nova Compo NEBF · Traditional | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 12/20/2019SE |
| K191306 | Llis, Vittra APSEBF · Traditional | Dentscare Ltda | 12/16/2019SE |
| K192260 | everX FlowEBF · Traditional | GC America, Inc. | 11/22/2019SE |
| K191980 | CLEARFIL MAJESTY ES FlowEBF · Traditional | Kuraray Noritake Dental, Inc. | 11/18/2019SE |
| K191385 | Brilliant ComponeerEBF · Traditional | Coltene/Whaledent AG | 10/29/2019SE |
| K182921 | Infinix Universal CompositeEBF · Traditional | Nobio , Ltd. | 09/13/2019SE |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APSEBF · Traditional | Dentscare Ltda | 09/04/2019SE |
| K182714 | Novidia Bulk Fill Flow CompositeEBF · Traditional | Nobio , Ltd. | 07/12/2019SE |
| K182780 | XP CompositeEBF · Traditional | S&C Polymer Silicon- Und Composite… | 07/03/2019SE |
| K182580 | Novidia Flowable CompositeEBF · Traditional | Nobio , Ltd. | 07/03/2019SE |
| K190597 | BRILLIANT EverGlow FlowEBF · Traditional | Coltene/Whaledent AG | 06/21/2019SE |
| K182430 | Clearfil Majesty IcEBF · Traditional | Kuraray Noritake Dental, Inc. | 05/03/2019SE |
| K182778 | LC Glossfill XREBF · Traditional | S&C Polymer Silicon- Und Composite… | 04/22/2019SE |
| K190453 | VisCalor bulkEBF · Special | Voco GmbH | 04/11/2019SE |
| K183380 | Tetric PowerFillEBF · Abbreviated | Ivoclar Vivadent, AG | 03/14/2019SE |
| K182869 | Fit SAEBF · Traditional | Shofu Dental Corporation | 01/09/2019SE |
| K183476 | 3M Filtek Universal RestorativeEBF · Traditional | 3M Espe Dental Products | 01/02/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | Parkell, Inc. | 12/14/2018SE |
| K182288 | TPH Spectra ST Flowable Composite RestorativeEBF · Traditional | Dentsply Sirona | 11/20/2018SE |
| K181689 | NexcompEBF · Traditional | Meta Biomed Co., Ltd. | 11/15/2018SE |
| K180463 | Apoller Flow Light Cure Flowable CompositeEBF · Abbreviated | Greenway Yw, LLC | 11/14/2018SE |
| K181312 | GrandioSO x-traEBF · Traditional | Voco GmbH | 08/22/2018SE |
| K181500 | BRILLIANT CriosEBF · Traditional | Coltene/Whaledent AG | 08/15/2018SE |
| K180613 | Estelite Universal FlowEBF · Traditional | Tokuyama Dental Corporation | 07/12/2018SE |
| K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown KitEBF · Traditional | Figaro Crowns, Inc. | 07/03/2018SE |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueEBF · Traditional | Zirkonzahn Srl | 06/18/2018SE |
| K180649 | BeautiCem Veneer KitEBF · Traditional | Shofu Dental Corporation | 06/11/2018SE |
| K173573 | Tetric CADEBF · Abbreviated | Ivoclar Vivadent, AG | 06/07/2018SE |
| K173500 | NMF004AEBF · Traditional | GC America, Inc. | 03/08/2018SE |
| K173275 | OmnichromaEBF · Traditional | Tokuyama Dental Corporation | 02/27/2018SE |
| K173643 | Trilor Disks, Blocks and ArchesEBF · Special | Bioloren S.R.L. | 02/24/2018SE |
| K171772 | Ecosite Bulk FillEBF · Traditional | Dmg USA, Inc. | 01/31/2018SE |
| K173124 | PEEK BiosolutionEBF · Traditional | Merz Dental GmbH | 12/18/2017SE |
| K172530 | BEAUTIFIL Flow Plus XEBF · Traditional | Shofu Dental Corporation | 12/06/2017SE |
| K172707 | Renamel MicrofillEBF · Traditional | Cosmedent, Inc. | 12/05/2017SE |
| K171815 | Registrado ScanEBF · Traditional | Voco GmbH | 11/15/2017SE |
| K170102 | Pekkton IvoryEBF · Traditional | Cendres+Metaux SA | 11/13/2017SE |
| K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi…EBF · Traditional | Swissmeditec GmbH | 10/02/2017SE |
| K171200 | Grandio blocsEBF · Traditional | Voco GmbH | 08/10/2017SE |
| K171147 | REVEAL BulkEBF · Traditional | Bisco, Inc. | 08/04/2017SE |
| K170896 | Admira Fusion x-baseEBF · Traditional | Voco GmbH | 06/29/2017SE |
| K161353 | ESTELITE BULK FILL FlowEBF · Traditional | Tokuyama Dental Corporation | 04/03/2017SE |
| K162967 | nuance UNIVERSALEBF · Traditional | Den-Mat Holdings, LLC | 03/24/2017SE |
| K163346 | MAZIC DuroEBF · Traditional | Vericom Co., Ltd. | 03/17/2017SE |
| K163480 | Renamel NANO +plusEBF · Traditional | Cosmedent, Inc. | 02/24/2017SE |
| K162323 | Tooth Shade Resin MaterialEBF · Traditional | Liaoning Upcera Co., Ltd. | 01/12/2017SE |
| K162261 | Ceramage UpEBF · Traditional | Shofu Dental Corporation | 01/11/2017SE |
| K163207 | Filtek One Bulk Fill RestorativeEBF · Traditional | 3M Company | 11/28/2016SE |
| K162537 | CAD/CAMouflage Milling BlockEBF · Special | Prismatik Dentalcraft, Inc. | 11/16/2016SE |
| K160049 | CharismaEBF · Traditional | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | 11/15/2016SE |
| K162257 | P1145 Dental RestorativeEBF · Traditional | Kerr Corporation | 11/07/2016SE |
| K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq…EBF · Traditional | Schutz Dental GmbH | 10/24/2016SE |
| K162107 | TPH Spectra+ Universal Composite RestorativeEBF · Traditional | Dentsply Sirona | 09/27/2016SE |
| K153476 | KATANA AVENCIA BlockEBF · Traditional | Kuraray Noritake Dental, Inc. | 08/23/2016SE |
| K152471 | Capo Bulk FillEBF · Traditional | Schuetz Dental GmbH | 08/04/2016SE |
| K153493 | Clip FlowEBF · Traditional | Voco GmbH | 07/29/2016SE |
| K160596 | Beautifil II LSEBF · Traditional | Shofu Dental Corporation | 07/27/2016SE |
| K160086 | SHOFU Enamel ConditionerEBF · Traditional | Shofu Dental Corporation | 07/21/2016SE |
| K152113 | BioHPP - breCAM.BioHPPEBF · Traditional | Bredent GmbH & Co. KG | 07/21/2016SE |
| K160425 | CAD/CAMouflage Milling BockEBF · Traditional | Prismatik Dentalcraft, Inc. | 07/15/2016SE |
| K153325 | Gradia PlusEBF · Traditional | GC America, Inc. | 07/12/2016SE |
| K153177 | Admira Fusion FlowEBF · Traditional | Voco GmbH | 06/30/2016SE |
| K153127 | everX PosteriorEBF · Traditional | GC America, Inc. | 05/20/2016SE |
| K152927 | Brilliant EverglowEBF · Traditional | Coltene/Whaledent AG | 04/28/2016SE |
| K153249 | Pulpdent Solo Flowable Composite with MCPEBF · Traditional | Pulpdent Corporation | 04/01/2016SE |
| K151700 | BEAUTIFIL II GingivaEBF · Traditional | Shofu Dental Corporation | 03/02/2016SE |
| K153191 | Calcium BridgeEBF · Traditional | Denali Corporation | 02/26/2016SE |
| K152373 | VITA VM LC FlowEBF · Abbreviated | Vita Zahnfabrik H.Rauter GmbH & Co. | 12/30/2015SE |
| K151699 | BEAUTIFIL II EnamelEBF · Traditional | Shofu Dental Corporation | 12/10/2015SE |
| K152004 | Nanova Universal CompositeEBF · Traditional | Nanova Biomaterials, Inc. | 11/17/2015SE |
| K151956 | Admira Fusion x-traEBF · Traditional | Voco GmbH | 10/20/2015SE |
| K151541 | G-FixEBF · Traditional | GC America, Inc. | 10/09/2015SE |
| K151514 | PrestigeEBF · Traditional | Danville Materials, LLC | 09/21/2015SE |
| K151088 | DMRC Bulk FillEBF · Traditional | Danville Materials, LLC | 08/28/2015SE |
| K151094 | Mosaic Universal CompositeEBF · Traditional | Ultradent Products, Inc. | 07/21/2015SE |
| K150784 | Admira FusionEBF · Traditional | Voco GmbH | 07/02/2015SE |
| K150218 | Fill-Up!EBF · Traditional | Coltene/Whaledent AG | 06/23/2015SE |
| K150623 | Nanova Flowable CompositeEBF · Traditional | Nanova Biomaterials, Inc. | 06/18/2015SE |
| K150393 | Tetric Evoflow Bulk FillEBF · Abbreviated | Ivoclar Vivadent, AG | 06/09/2015SE |
| K143524 | Fiber Disks and Blocks (TRINIA)EBF · Traditional | Bicon, LLC | 06/02/2015SE |
| K143694 | Rhondium One-Visit-Crown(OVC)EBF · Traditional | Rhondium, Ltd. | 05/15/2015SE |
| K143679 | Nuance FLOWEBF · Traditional | Den-Mat Holdings, LLC | 05/01/2015SE |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XEBF · Traditional | Kettenbach GmbH & Co. KG | 03/25/2015SE |
| K143209 | SonicFill 2EBF · Traditional | Sybron Dental Specialties | 02/05/2015SE |
| K142389 | Variolink EstheticEBF · Abbreviated | Ivoclar Vivadent, AG | 11/25/2014SE |
| K141994 | Bulk Fill Flowable CompositeEBF · Traditional | Novocol, Inc. | 11/14/2014SE |
| K140976 | Enaden FlowEBF · Traditional | Km Corporation | 07/10/2014SE |
| K140512 | Ufill Bulk Fill Posterior Flowable CompositeEBF · Traditional | Juno Dentistry LP | 07/02/2014SE |
| K132115 | Absolute Dentin 2EBF · Traditional | Parkell, Inc. | 06/25/2014SE |
| K133850 | Camouflage Nanohybrid Composite (Universal & Flowable)EBF · Traditional | Prismatik Dentalcraft, Inc. | 06/04/2014SE |
| K141081 | Filtek Bulk Fill Posterior RestroativeEBF · Traditional | 3M Espe Dental Products | 05/08/2014SE |
| K133182 | HTFX-222EBF · Traditional | GC America, Inc. | 04/09/2014SE |
| K133824 | CerasmartEBF · Traditional | GC America, Inc. | 03/14/2014SE |
| K133608 | TriniaEBF · Abbreviated | Bicon, LLC | 03/14/2014SE |
| K132748 | Beautifil E Posterior, Beautifil BulkEBF · Traditional | Shofu Dental Corporation | 12/04/2013SE |
| K131753 | MeridianEBF · Abbreviated | Ab Ardent | 11/14/2013SE |
| K132141 | Beautifil Bulk FlowableEBF · Traditional | Shofu Dental Corporation | 10/03/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3016-2026 Class II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1)…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the… | Henry Schein Inc. | 07/09/2026Open, Classified |
| Z-3015-2026 Class II | Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the… | Henry Schein Inc. | 07/09/2026Open, Classified |
| Z-3068-2024 Class II | Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk…Due to a manufacturing issue, red particulates present in the expressed composite. | Ultradent Products, Inc. | 08/02/2024Open, Classified |
| Z-3067-2024 Class II | Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog…Due to a manufacturing issue, red particulates present in the expressed composite. | Ultradent Products, Inc. | 08/02/2024Open, Classified |
| Z-3066-2024 Class II | Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number:…Due to a manufacturing issue, red particulates present in the expressed composite. | Ultradent Products, Inc. | 08/02/2024Open, Classified |
| Z-0053-2021 Class II | PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured…Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. | Ultradent Products, Inc. | 08/31/2020Terminated |
| Z-0028-2020 Class II | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive…The metal cannula are potentially too loose and may become loose when applying the filing material. | Voco GmbH | 07/09/2019Terminated |
| Z-0708-2020 Class II | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The…The product was mislabeled with an incorrect expiration date. | Rhondium Limited | 01/31/2019Completed |
| Z-0668-2018 Class III | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | Ivoclar Vivadent, Inc. | 08/03/2017Terminated |
| Z-0667-2018 Class III | Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | Ivoclar Vivadent, Inc. | 08/03/2017Terminated |
| Z-0666-2018 Class III | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | Ivoclar Vivadent, Inc. | 08/03/2017Terminated |
| Z-0665-2018 Class III | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | Ivoclar Vivadent, Inc. | 08/03/2017Terminated |
| Z-2052-2015 Class II | Block Versions Used by Dental Offices often referred to as chairside milling: Lava…3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These… | 3M Company - Health Care Business | 06/15/2015Terminated |
| Z-2259-2013 Class II | NX3 Try-In Gel. The product is used as a tooth shade resin material.Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel… | Kerr/Pentron, DBA Kerr Corporation and… | 09/13/2013Terminated |
| Z-0157-2012 | 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | Kerr/pentron Dba Kerr Corporation And… | 03/31/2011Terminated |
| Z-0156-2012 | 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | Kerr/pentron Dba Kerr Corporation And… | 03/31/2011Terminated |
| Z-0155-2012 | 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | Kerr/pentron Dba Kerr Corporation And… | 03/31/2011Terminated |
| Z-0154-2012 | 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | Kerr/pentron Dba Kerr Corporation And… | 03/31/2011Terminated |
| Z-0153-2012 | 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | Kerr/pentron Dba Kerr Corporation And… | 03/31/2011Terminated |
| Z-0990-2012 | Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No.…The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable… | Sybron Dental Specialties | 03/03/2011Terminated |
| Z-0989-2012 | Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A…The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable… | Sybron Dental Specialties | 03/03/2011Terminated |
| Z-1007-2012 | Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the device…The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite… | Sybron Dental Specialties | 10/22/2010Terminated |
| Z-1006-2012 | Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device…The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite… | Sybron Dental Specialties | 10/22/2010Terminated |
| Z-1005-2012 | Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the…The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite… | Sybron Dental Specialties | 10/22/2010Terminated |
| Z-1000-2012 | Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended…The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite… | Sybron Dental Specialties | 10/22/2010Terminated |
| Z-0716-2011 | SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4…Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution… | Patterson Dental Supply, Inc. | 10/15/2010Terminated |
| Z-1115-2012 | Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended…A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as… | Kerr Corporation | 08/19/2010Terminated |
| Z-0916-2010 | Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured…Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite… | Sybron Dental Specialties | 02/23/2009Terminated |
| Z-0270-2009 | PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0269-2009 | PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0268-2009 | PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY)…Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0267-2009 | PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental…Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0266-2009 | PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0265-2009 | PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0264-2009 | PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0263-2009 | PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0262-2009 | PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0261-2009 | PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0260-2009 | PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental…Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0259-2009 | PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0258-2009 | PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0257-2009 | PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0256-2009 | PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0255-2009 | PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0254-2009 | PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0253-2009 | PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0252-2009 | PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0251-2009 | PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0250-2009 | PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |
| Z-0249-2009 | PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | Kerr Corp | 09/05/2008Terminated |