Material, Impression
FDA product code ELW · Class II (moderate risk) · 21 CFR 872.3660 · Dental
402510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Heraeus Kulzer, Inc. 21
- Zhermack S.P.A. 19
- Dentsply Intl. 18
- Cavex Holland BV 16
- GC America, Inc. 15
- Zhermack Dental Production 11
- Sybron Dental Specialties, Inc. 10
- Harry J. Bosworth Co. 10
- Espe Dental AG 10
- Crown Delta Corp. 10
- Kerr Corporation 8
- Espe GmbH & Co. Kg. 7
- Espe GmbH (Us) 7
- Coe Laboratories, Inc. 7
- Kettenbach GmbH & Co. KG 6
- Coltene, Inc. 6
- Vericom Co., Ltd. 5
- Cutter Laboratories, Inc. 5
- 3M Company 5
- Buffalo Dental Mfg. Co., Inc. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254112 | Dia-X Sil BiteELW · Traditional | DiaDent Group International | 03/19/2026SE |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional | Vigodent Indústria E Comercio Ltda | 10/31/2025SE |
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated | Dent4you AG | 06/27/2025SE |
| K241924 | Elastic Impression MaterialELW · Abbreviated | Beijing Okvd Biological Technology , Ltd. | 12/27/2024SE |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…ELW · Traditional | Dent4you AG | 11/15/2024SE |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional | B&E Korea Co., Ltd. | 02/13/2024SE |
| K223892 | DentMix VPS Impression MaterialELW · Traditional | Innovative Product Brands, Inc. | 04/27/2023SE |
| K213175 | No Stress ImpressELW · Traditional | No Stress Impress, LLC | 01/19/2023SE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…ELW · Traditional | Prevest Denpro Limited | 09/09/2022SE |
| K221668 | Dental Impression MaterialELW · Traditional | Chemoment Materials Co.,Ltd | 08/08/2022SE |
| K213890 | IMICRYL Impression MaterialsELW · Traditional | Imicryl Dis Malzemeleri San. VE Tic. A.S. | 02/11/2022SE |
| K220257 | PermadyneELW · Traditional | 3M Deutschland GmbH | 02/01/2022SE |
| K220097 | PRESIDENT The OriginalELW · Traditional | Coltène/Whaledent AG | 01/13/2022SE |
| K211489 | Dental Impression MaterialELW · Traditional | Nanchang Dental Bright Technology Co., Ltd. | 07/28/2021SE |
| K203824 | VPS Impression MaterialELW · Traditional | Hygedent, Inc. | 04/19/2021SE |
| K210041 | HySil Plus Impression MaterialsELW · Traditional | Osstem Implant Co., Ltd. | 03/18/2021SE |
| K201483 | Impression MaterialELW · Traditional | Zhengzhou Huaer Electro Optics Technology Co.… | 10/08/2020SE |
| K201684 | A-Silicone for Bite RegistrationELW · Traditional | Shandong Huge Dental Material Corporation | 09/24/2020SE |
| K201184 | Lascod Impression MaterialsELW · Traditional | Lascod Spa | 05/05/2020SE |
| K192941 | HySil Super Fast Impression MaterialsELW · Traditional | Osstem Implant Co., Ltd. | 01/30/2020SE |
| K190571 | StoneBite and StoneBite scanELW · Abbreviated | Dreve Dentamid GmbH | 11/07/2019SE |
| K191034 | VPS Impression MaterialELW · Traditional | Hygedent, Inc. | 09/04/2019SE |
| K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteELW · Traditional | Hrs Co., Ltd. | 11/28/2018SE |
| K181236 | HySil Impression MaterialsELW · Traditional | Osstem Implant Co., Ltd. | 09/13/2018SE |
| K181011 | AIM2ELW · Traditional | GC America, Inc. | 07/12/2018SE |
| K180565 | Peak NS033CF, Peak NS017CFELW · Traditional | Neosil Co., Ltd. | 06/13/2018SE |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoELW · Abbreviated | Dreve Dentamid GmbH | 04/13/2018SE |
| K173318 | Rapid HB, Rapid LB, Rapid MBELW · Traditional | 3M Deutschland GmbH | 10/31/2017SE |
| K170812 | HygePLUS Alginate Impression MaterialELW · Traditional | Hygedent, Inc. | 07/26/2017SE |
| K170736 | HySil Impression MaterialsELW · Traditional | Osstem Implant Co., Ltd. | 06/07/2017SE |
| K152615 | Vonflex SELW · Traditional | Vericom Co., Ltd. | 11/03/2016SE |
| K161774 | i-SilELW · Traditional | Spident Co., Ltd. | 09/30/2016SE |
| K160097 | Image Fast Set, Image Regular SetELW · Traditional | Sybron Dental Specialties | 08/05/2016SE |
| K160441 | Identic and KromaFaze Alginate Dental Impression MaterialsELW · Traditional | Kerr Corporation | 06/30/2016SE |
| K152826 | NoCordELW · Traditional | Centrix, Inc. | 05/27/2016SE |
| K152766 | CharmFlexELW · Traditional | Dentkist, Inc. | 03/08/2016SE |
| K152861 | Aquasil Ultra + Smart Wetting Impression MaterialELW · Special | Dentply International, Inc. | 03/04/2016SE |
| K152518 | Vonflex S PuttyELW · Traditional | Vericom Co., Ltd. | 11/30/2015SE |
| K152349 | Star+ VPS Scannable Impression MaterialELW · Traditional | Danville Materials, LLC | 11/23/2015SE |
| K151535 | Cavex Cream AlginateELW · Traditional | Cavex Holland BV | 10/28/2015SE |
| K152180 | PeakELW · Traditional | Neosil Co., Ltd. | 10/22/2015SE |
| K151262 | Hyflex Heavy, Hyflex Mono, Hyflex LightELW · Traditional | Osstem Implant Co., Ltd. | 09/21/2015SE |
| K151150 | ElementsELW · Traditional | Pac-Dent International, Inc. | 07/28/2015SE |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD SyringeELW · Abbreviated | Ivoclar Vivadent, Inc. | 04/03/2015SE |
| K143382 | DentiAnn Smart SilELW · Traditional | Seilglobal Co., Ltd. | 02/23/2015SE |
| K141092 | MARK3ELW · Traditional | Cavex Holland BV | 12/04/2014SE |
| K140966 | Vonflex S BiteELW · Traditional | Vericom Co., Ltd. | 08/15/2014SE |
| K132869 | SildentELW · Traditional | Hrs Co., Ltd. | 06/19/2014SE |
| K140602 | Flash Penta MB Quick, Flash MB QuickELW · Traditional | 3M Espe AG | 06/05/2014SE |
| K133071 | Elastic Impression MaterialELW · Traditional | Rizhao Huge Dental Industry Co., Ltd. | 05/28/2014SE |
| K140074 | Hygedent Alginate Impression MaterialELW · Traditional | Hygedent, Inc. | 05/21/2014SE |
| K134008 | Md-Flex Heavy BodyELW · Traditional | Meta Biomed, Inc. | 04/09/2014SE |
| K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightELW · Traditional | Osstem Germany GmbH | 03/07/2014SE |
| K133436 | Flash Ar; Flash Ar QuickELW · Traditional | 3M Deutschland GmbH | 03/07/2014SE |
| K133400 | Flash BiteELW · Traditional | 3M Espe AG | 03/06/2014SE |
| K132599 | Smilebond SystemELW · Traditional | Millennium Company, LLC | 02/25/2014SE |
| K131510 | Polydimethylsiloxane Impression MaterialELW · Traditional | Blackwell Device Consulting | 12/20/2013SE |
| K130920 | Correct Plus 1ELW · Traditional | Pentron Clinical | 07/02/2013SE |
| K131404 | Flash Ar Penta / Flash Ar Penta QuickELW · Traditional | 3M Deutschland GmbH | 05/30/2013SE |
| K130869 | Take 1 AdvanceELW · Traditional | Sybron Dental Specialties | 05/30/2013SE |
| K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLELW · Traditional | Heraeus Kulzer, LLC | 05/17/2013SE |
| K121824 | Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2ELW · Traditional | Lascod Spa | 08/23/2012SE |
| K120914 | Flexitime Fast & Scan Light FlowELW · Special | Heraeus Kulzer, LLC | 07/25/2012SE |
| K113574 | Flexitime Monophase Pro ScanELW · Traditional | Heraeus Kulzer, LLC | 07/13/2012SE |
| K120013 | Tempspan Clear MatrixELW · Traditional | Pentron Clinical | 05/22/2012SE |
| K120521 | GC Blue SiliconeELW · Traditional | GC America, Inc. | 05/10/2012SE |
| K120438 | Flash (Different Materials)ELW · Traditional | 3M Deutschland GmbH | 05/02/2012SE |
| K113406 | Aquasil Ultra Smart Wetting Impression MaterialELW · Traditional | Dentsply International, Inc. | 02/13/2012SE |
| K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…ELW · Special | Kettenbach GmbH & Co. KG | 11/14/2011SE |
| K113263 | Arges Imaging Contrast SprayELW · Traditional | Arges Imaging, Inc. | 11/14/2011SE |
| K110871 | Fit Checker AdvancedELW · Traditional | GC America, Inc. | 06/17/2011SE |
| K110092 | Take 1 Advanced Rigid TrayELW · Traditional | Kerr Corporation | 04/08/2011SE |
| K110378 | Impression CompoundELW · Traditional | Spofadental | 04/05/2011SE |
| K103586 | Ios Fastscan SprayELW · Traditional | Ios Technnologies, Inc. | 03/30/2011SE |
| K110050 | Fit Test C&BELW · Traditional | Voco GmbH | 03/28/2011SE |
| K103346 | Delikit Putty, Delikit Heavy Body, Delikit Light BodyELW · Traditional | Sherpa Korea | 02/11/2011SE |
| K102836 | Bonasil A+ Impression MaterialsELW · Traditional | Dmp, Ltd. | 01/13/2011SE |
| K102770 | Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium…ELW · Traditional | Heraeus Kulzer, LLC | 12/21/2010SE |
| K102739 | Hydrocolor 5ELW · Traditional | Cascades Device Consulting Associates | 12/08/2010SE |
| K103164 | Vonflex Heavy, Vinflex LightELW · Traditional | Vericom Co., Ltd. | 11/10/2010SE |
| K101617 | Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…ELW · Traditional | Heraeus Kulzer, LLC | 09/07/2010SE |
| K092176 | Take 1 Advanced Rigid TrayELW · Traditional | Kerr Corporation | 01/28/2010SE |
| K091613 | Take 1ELW · Traditional | Kerr Corp. | 10/07/2009SE |
| K092867 | Identium Heavy, Medium, Medium Soft, LightELW · Traditional | Kettenbach GmbH & Co. KG | 10/01/2009SE |
| K092319 | Star VPS, Model 80014-01, First Quater, Model 90649, First Half, Model 89387ELW · Traditional | Danville Materials, Inc. | 09/16/2009SE |
| K091494 | Flexitime FlowELW · Traditional | Heraeus Kulzer, Inc. | 07/31/2009SE |
| K091267 | Vonflex PuttyELW · Traditional | Vericom Co., Ltd. | 05/06/2009SE |
| K083739 | Hydrorise and HydrosystemELW · Traditional | Zhermack S.P.A. | 03/26/2009SE |
| K083701 | Panasil Initial Contact and Panasil TrayELW · Special | Kettenbach GmbH & Co. KG | 01/09/2009SE |
| K082591 | Flexitime BiteELW · Traditional | Heraeus Kulzer, Inc., Dental Products Division | 12/05/2008SE |
| K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactELW · Traditional | Kettenbach GmbH & Co. KG | 09/08/2008SE |
| K082157 | Kettosil and SilginatELW · Traditional | Kettenbach GmbH & Co. KG | 08/06/2008SE |
| K081017 | Template and Counter-FitELW · Traditional | Clinician'S Choice Dental Products, Inc. | 08/04/2008SE |
| K081084 | Colorise RigidELW · Special | Zhermack S.P.A. | 05/14/2008SE |
| K081120 | Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration MaterialsELW · Traditional | Kettenbach GmbH & Co. KG | 05/01/2008SE |
| K080338 | Cuttersil Activator Universal PlusELW · Traditional | Heraeus Kulzer,GmbH | 04/21/2008SE |
| K080882 | Cerec Opti SprayELW · Traditional | Sirona Dental Systems GmbH | 04/11/2008SE |
| K080514 | PECD-01 and Pecd QUICK-01ELW · Special | 3M Espe AG Dental Products | 03/26/2008SE |
| K080130 | Occlufast CadELW · Special | Zhermack S.P.A. | 03/14/2008SE |
| K073475 | System PlusELW · Traditional | Continental Dental Laboratory | 03/10/2008SE |
| K073005 | Elite GlassELW · Traditional | Zhermack S.P.A. | 12/12/2007SE |
| K072577 | Bisico Impression Silicones & AlginatesELW · Traditional | Bisico GmbH & CO KG | 12/05/2007SE |
| K072622 | Standout 2ELW · Traditional | Kerr Corp. | 12/04/2007SE |
| K072245 | Emulate AdvancedELW · Traditional | Cavex Holland BV | 11/08/2007SE |
| K071192 | Blugoo HDELW · Traditional | Lancer Orthodontics, Inc. | 06/22/2007SE |
| K070677 | ColoriseELW · Traditional | Zhermack S.P.A. | 05/11/2007SE |
| K070700 | FreealginELW · Traditional | Zhermack S.P.A. | 04/25/2007SE |
| K062400 | Impressix, Colorchange AlginateELW · Traditional | Cavex Holland BV | 11/16/2006SE |
| K060891 | VirtualELW · Traditional | Ivoclar Vivadent, Inc. | 07/17/2006SE |
| K061267 | Simulate, Color Change AlginateELW · Traditional | Cavex Holland BV | 07/10/2006SE |
| K061427 | Pre-Impression Conditioning SolutionELW · Traditional | Dentsply Intl. | 06/26/2006SE |
| K053619 | ColorbiteELW · Traditional | Zhermack S.P.A. | 03/01/2006SE |
| K053427 | Fresh, Dental Impression MaterialELW · Traditional | Exacta Dental Products, Inc. | 01/13/2006SE |
| K051933 | Expasyl Power ApplicatorELW · Traditional | Sybron Dental Specialties, Inc. | 01/03/2006SE |
| K052455 | ImpressixELW · Traditional | Cavex Holland BV | 11/23/2005SE |
| K053014 | Poly Siloxane Impression MaterialELW · Traditional | Clinician'S Choice Dental Products, Inc. | 11/15/2005SE |
| K053018 | Poly Siloxane Impression MaterialELW · Traditional | Millennium Dental International, Inc. | 11/08/2005SE |
| K052409 | Silgimix Alginate Replacement Impression MaterialELW · Traditional | Sultan Chemists, Inc. | 10/20/2005SE |
| K052090 | Splash! Impression Material DeviceELW · Traditional | Discus Dental, Inc. | 08/05/2005SE |
| K051797 | Future Wash/YpsELW · Special | 3M Espe AG Dental Products | 07/21/2005SE |
| K050417 | Elite ImplantELW · Traditional | Zhermack S.P.A. | 07/19/2005SE |
| K051424 | Hydrogum 5ELW · Traditional | Zhermack S.P.A. | 07/15/2005SE |
| K051535 | Modification To:Registrado X-TraELW · Special | Voco GmbH | 06/28/2005SE |
| K051243 | Jet Blue BiteELW · Traditional | Coltene/Whaledent AG | 06/23/2005SE |
| K051207 | Cavex OrthotraceELW · Traditional | Cavex Holland BV | 06/21/2005SE |
| K050604 | Kerr VPS Impression MaterialELW · Traditional | Sybron Dental Specialties, Inc. | 04/15/2005SE |
| K043493 | Fusion Putty TypeELW · Traditional | GC America, Inc. | 03/04/2005SE |
| K043054 | Genie Magic Mix Ultra Hydrophilic Impression MaterialELW · Traditional | Sultan Chemists, Inc. | 02/18/2005SE |
| K050013 | RetractofoamELW · Traditional | Coltene/Whaledent AG | 02/09/2005SE |
| K043471 | Fusion FastELW · Traditional | GC America, Inc. | 01/27/2005SE |
| K043118 | Hydrogum SoftELW · Traditional | Zhermack S.P.A. | 01/24/2005SE |
| K042878 | Flexitime XtremeELW · Traditional | Heraeus Kulzer, Inc. | 12/17/2004SE |
| K043131 | TorpicalginELW · Traditional | Zhermack S.P.A. | 12/15/2004SE |
| K042860 | Correct Dental Impression MaterialELW · Traditional | Handae Chemical Co., Ltd. | 12/03/2004SE |
| K041398 | GC FusionELW · Traditional | GC America, Inc. | 06/25/2004SE |
| K041229 | Multiple (Addition Silicone Impression Material)ELW · Traditional | Cosmedent, Inc. | 06/17/2004SE |
| K041028 | Crown Delta Hydrophilic Impression MaterialELW · Traditional | Crown Delta Corp. | 05/14/2004SE |
| K040053 | Precision VPS Impression MaterialELW · Traditional | Discus Dental, Inc. | 03/25/2004SE |
| K032708 | Plastalgin and Plastalgin OrthoELW · Traditional | Septodont | 11/20/2003SE |
| K032289 | Fit Checker IIELW · Traditional | GC America, Inc. | 10/20/2003SE |
| K031439 | Alginate Impression Material III (Fast & Regular)ELW · Traditional | Harry J. Bosworth Co. | 10/02/2003SE |
| K032116 | Tulip ColorswitchELW · Traditional | Cavex Holland BV | 09/30/2003SE |
| K032001 | Poly Q (Garant L, Penta M, Penta H)ELW · Traditional | 3M Espe AG Dental Products | 08/11/2003SE |
| K031484 | Stand OutELW · Traditional | Kerr Corp. | 07/03/2003SE |
| K030776 | Mega Bite Registration - Dental Bite Registration MaterialELW · Traditional | Discus Dental, Inc. | 05/09/2003SE |
| K030414 | Genie Ultra Hydrophilic Impression MaterialELW · Traditional | Sultan Chemists, Inc. | 04/09/2003SE |
| K030318 | P2 PolyetherELW · Traditional | Heraeus Kulzer, Inc. | 04/03/2003SE |
| K023751 | ExajetELW · Traditional | GC America, Inc. | 01/22/2003SE |
| K024041 | Zetaplus SoftELW · Special | Zhermack S.P.A. | 12/18/2002SE |
| K024034 | Occlufast RockELW · Special | Zhermack S.P.A. | 12/18/2002SE |
| K023466 | Tulip Alginate Impression MaterialELW · Traditional | Cavex Holland BV | 12/13/2002SE |
| K022653 | Elite MonophaseELW · Traditional | Zhermack S.P.A. | 10/28/2002SE |
| K022430 | Iso FunctionalELW · Traditional | GC America, Inc. | 10/18/2002SE |
| K022066 | Registrado X-TraELW · Traditional | Voco GmbH | 08/14/2002SE |
| K021416 | Aquasil Ultra Monophase/Heavy/Lv Smart Wetting Impression MaterialELW · Special | Dentsply Intl. | 05/13/2002SE |
| K021413 | Aquasil Ultra Rigid Smart Wetting Impression MaterialELW · Special | Dentsply Intl. | 05/10/2002SE |
| K021410 | Aquasil Ultra XLV Smart Wetting Impression MaterialELW · Special | Dentsply Intl. | 05/08/2002SE |
| K020242 | Emulate Fast Set and Emulate Regular SetELW · Traditional | Cavex Holland BV | 04/17/2002SE |
| K013859 | Rhodia Bite Registration MaterialELW · Traditional | Rhodia, Inc. | 01/29/2002SE |
| K012767 | S & C Hydro Vinyl Polysiloxane Impression MaterialELW · Traditional | S & C Polymer GmbH | 11/01/2001SE |
| K012517 | CEREC3 VitablocksELW · Traditional | Sirona Dental Systems GmbH | 11/01/2001SE |
| K013336 | Xantalgin CronoELW · Traditional | Cavex Holland BV | 10/29/2001SE |
| K013237 | StatusblueELW · Abbreviated | Dmg USA, Inc. | 10/22/2001SE |
| K013236 | LuxabiteELW · Abbreviated | Dmg USA, Inc. | 10/17/2001SE |
| K013140 | Rhodia Hydrophilic Dental Impression MaterialELW · Traditional | Rhodia, Inc. | 10/10/2001SE |
| K013129 | Rhodia Dental Putty Impression MaterialELW · Traditional | Rhodia, Inc. | 10/10/2001SE |
| K012405 | Extrude ModifiedELW · Traditional | Sybron Dental Specialties, Inc. | 09/04/2001SE |
| K011785 | Novel Print Cyan AlginatesELW · Traditional | Manufacturera Dental Continental | 09/04/2001SE |
| K011452 | Cavex StabisilELW · Traditional | Cavex Holland BV | 07/19/2001SE |
| K011419 | Cavex ColorchangeELW · Traditional | Cavex Holland BV | 07/16/2001SE |
| K011450 | Silicone Impression MaterialELW · Traditional | Northeast Resins & Silicones, LLC | 06/13/2001SE |
| K010994 | Take One Bite ModifiedELW · Traditional | Kerr Corp. | 04/23/2001SE |
| K010926 | R-Si-Line Metal-BiteELW · Traditional | R-Dental Dentalerzeugnisse GmbH | 04/12/2001SE |
| K003808 | Take 1ELW · Traditional | Sybron Dental Specialties, Inc. | 03/01/2001SE |
| K003650 | Permlastic 3ELW · Traditional | Sybron Dental Specialties, Inc. | 02/15/2001SE |
| K003930 | Flextime Magnum 360ELW · Traditional | Heraeus Kulzer, Inc. | 02/01/2001SE |
| K003426 | Alginate Impression MaterialELW · Traditional | Rite-Dent Manufacturing Corp. | 01/23/2001SE |
| K001655 | Permlastic 2ELW · Traditional | Kerr Corp. | 08/10/2000SE |
| K001414 | KwikkmodelELW · Traditional | R-Dental Dentalerzeugnisse GmbH | 08/09/2000SE |
| K001876 | Take 1 BiteELW · Traditional | Sybron Dental Specialties, Inc. | 07/21/2000SE |
| K001218 | Correct PlusELW · Traditional | Jeneric/Pentron, Inc. | 07/05/2000SE |
| K000686 | Krom-Alginate and Alginate PlusELW · Traditional | Cavex Holland BV | 05/25/2000SE |
| K994027 | Activator PasteELW · Traditional | Harry J. Bosworth Co. | 04/13/2000SE |
| K000878 | HonigumELW · Abbreviated | Dmg USA, Inc. | 04/11/2000SE |
| K000629 | FlextimeELW · Traditional | Heraeus Kulzer, Inc. | 04/05/2000SE |
| K000595 | Dimension Penta LELW · Traditional | Espe Dental AG | 04/05/2000SE |
| K000591 | Dimension Penta H, Dimension Penta H QuickELW · Traditional | Espe Dental AG | 03/30/2000SE |
| K000588 | Dimension Garant L, Dimension Garant L QuickELW · Traditional | Espe Dental AG | 03/30/2000SE |
| K994172 | Cerec 3ELW · Special | Sirona Dental Systems GmbH | 02/08/2000SE |
| K994193 | Impregum Penta DuosoftELW · Traditional | Espe Dental AG | 01/28/2000SE |
| K994192 | Impregum Penta M MonosoftELW · Traditional | Espe Dental AG | 01/28/2000SE |
| K994190 | Impregum Garant L DuosoftELW · Traditional | Espe Dental AG | 01/27/2000SE |
| K994077 | Aroma Fine (Normal and Fast Set)ELW · Traditional | GC America, Inc. | 01/27/2000SE |
| K992001 | Tray-LinkELW · Traditional | Silicon-Und Composite Spezialitaten GmbH | 11/02/1999SE |
| K992897 | Impregum PentaELW · Special | Espe Dental AG | 09/08/1999SE |
| K992895 | Impregum FELW · Special | Espe Dental AG | 09/08/1999SE |
| K991631 | Fastray LCELW · Traditional | Harry J. Bosworth Co. | 07/26/1999SE |
| K991490 | Alginate Impression Material II (Fast & Regular Set)ELW · Traditional | Harry J. Bosworth Co. | 07/15/1999SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1100-2022 Class II | Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly…Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body… | Clinician's Choice Dental Products Inc. | 03/18/2022Terminated |
| Z-0719-2017 Class II | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY…The firm received complaints claiming the dental material failed to set up. As the dental material ages, the… | Ivoclar Vivadent, Inc. | 11/09/2016Terminated |
| Z-0718-2017 Class II | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code…The firm received complaints claiming the dental material failed to set up. As the dental material ages, the… | Ivoclar Vivadent, Inc. | 11/09/2016Terminated |
| Z-0717-2017 Class II | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461…The firm received complaints claiming the dental material failed to set up. As the dental material ages, the… | Ivoclar Vivadent, Inc. | 11/09/2016Terminated |
| Z-0535-2014 Class II | 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS…Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the… | 3M Company - Health Care Business | 11/21/2013Terminated |
| Z-0812-2013 Class III | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml…Incorrect packaging of regular set and fast set cartridges. | Ultradent Products, Inc. | 02/04/2013Terminated |
| Z-0811-2013 Class III | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml…Incorrect packaging of regular set and fast set cartridges. | Ultradent Products, Inc. | 02/04/2013Terminated |
| Z-0268-2013 Class II | The brand name of the device is AlgiNot, a dental impression material. Product Part…The firm recalled the product because it may cure harder than expected within the shelf life, which could… | Kerr Corporation | 02/21/2012Terminated |
| Z-1146-2012 | Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended…Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It… | Sybron Dental Specialties | 11/04/2010Terminated |