Resin, Root Canal Filling
FDA product code KIF · Class II (moderate risk) · 21 CFR 872.3820 · Dental
147510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Meta Biomed Co., Ltd. 9
- Innovative Bioceramix, Inc. 8
- Maruchi 7
- DiaDent Group International 6
- Pulpdent Corp. 6
- Sybron Dental Specialties, Inc. 6
- Dentsply Intl. 5
- Septodont, Inc. 5
- Ultradent Products, Inc. 5
- Angelus Industria DE Produtos Odontologicos S/A 5
- Mediclus Co., Ltd. 4
- Vericom Co., Ltd. 4
- Angelus Industria DE Productos Odontologicos 3
- Avalon Biomed, Inc. 3
- Neodental Chemical Products Co., Ltd. 2
- Wallace A. Erickson & Co. 2
- Drfp , Ltd. 2
- Dentsply Interntional 2
- Kerr Corporation 2
- Dentsply International, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262050 | Vioseal XKIF · Traditional | Spident Co., Ltd. | 09/11/2026SE |
| K253909 | NeoPEX Pre-Mixed Obturation PasteKIF · Traditional | NuSmile, Ltd. | 09/04/2026SE |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/25/2026SE |
| K261415 | Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 06/29/2026SE |
| K253167 | Any-PasteKIF · Traditional | Mediclus Co., Ltd. | 01/12/2026SE |
| K252890 | ZenSeal ProKIF · Traditional | Kerr Corporation | 01/07/2026SE |
| K251465 | Root canal repair materials (nRoot BP)KIF · Traditional | Enpuno Biotechnology Co., Ltd. | 09/25/2025SE |
| K252285 | Well-Root PTKIF · Traditional | Vericom Co., Ltd. | 09/19/2025SE |
| K251884 | One-Fil Putty InjectableKIF · Special | Mediclus Co., Ltd. | 08/22/2025SE |
| K251390 | MTA vptKIF · Traditional | Voco GmbH | 07/03/2025SE |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP)KIF · Traditional | Enpuno Co., Ltd. | 06/11/2025SE |
| K243353 | One-Fil PuttyKIF · Traditional | Mediclus Co., Ltd. | 03/14/2025SE |
| K243546 | AH Plus Endodontic SealerKIF · Traditional | Dentsply Sirona, Inc. | 02/13/2025SE |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)KIF · Traditional | Longly Biotechnology (Wuhan) Co., Ltd. | 12/12/2024SE |
| K242702 | VioSealKIF · Traditional | Spident Co., Ltd. | 11/07/2024SE |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP)KIF · Traditional | Longly Biotechnology (Wuhan) Co., Ltd. | 10/03/2024SE |
| K241457 | Vista BC PuttyKIF · Traditional | Inter-Med, Inc. | 08/28/2024SE |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R…KIF · Traditional | Shiva Products | 07/30/2024SE |
| K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)KIF · Traditional | Enpuno Biotechnology Co., Ltd. | 05/28/2024SE |
| K240365 | Bioceramic Root Repair Material (C-Root BP)KIF · Traditional | Beijing C-Root Dental Medical Devices Co., Ltd. | 05/10/2024SE |
| K232182 | One-FilKIF · Traditional | Mediclus Co., Ltd. | 01/26/2024SE |
| K232299 | CeraPuttyKIF · Traditional | Meta Biomed Co., Ltd. | 09/29/2023SE |
| K231480 | Bright MTA Sealer PlusKIF · Traditional | Genoss Co., Ltd. | 07/28/2023SE |
| K231387 | EndofillKIF · Traditional | Lumendo AG | 07/10/2023SE |
| K231259 | iRoot SP PlusKIF · Special | Innovative Bioceramix, Inc. | 05/31/2023SE |
| K230010 | ADSEAL PlusKIF · Traditional | Meta Biomed Co., Ltd. | 04/13/2023SE |
| K230797 | SmartMTA CapsuleKIF · Traditional | Sprig Oral Health Technologies, Inc. | 03/24/2023SE |
| K213757 | Endocem MTA Premixed RegularKIF · Traditional | Maruchi | 02/14/2023SE |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…KIF · Traditional | Innovative Bioceramix, Inc. | 11/22/2022SE |
| K221811 | Vista BC SealerKIF · Traditional | Inter-Med, Inc. | 11/21/2022SE |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…KIF · Traditional | Prevest Denpro Limited | 05/23/2022SE |
| K212983 | Injectable Root Canal Bioceramic SealerKIF · Traditional | Beijing C-Root Dental Medical Devices Co., Ltd. | 12/08/2021SE |
| K211905 | UltraCal XSKIF · Traditional | Ultradent Products, Inc. | 10/13/2021SE |
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2gKIF · Traditional | Septodont | 09/16/2021SE |
| K211995 | Sonendo Filling Material 5CKIF · Traditional | Sonendo, Inc. | 08/27/2021SE |
| K212229 | White Endoseal MTAKIF · Special | Maruchi | 08/13/2021SE |
| K211799 | Biodentine XP 500, Biodentine XP 200KIF · Traditional | Septodont | 08/10/2021SE |
| K210904 | Metapaste PlusKIF · Traditional | Meta Biomed Co., Ltd. | 06/30/2021SE |
| K202617 | Metapex PlusKIF · Traditional | Meta Biomed Co., Ltd. | 04/14/2021SE |
| K210333 | DiaPasteKIF · Special | DiaDent Group International | 03/25/2021SE |
| K202015 | White ENDOSEAL MTAKIF · Traditional | Maruchi | 03/24/2021SE |
| K202281 | EDS Bioceramic Sealer (Bioseal)KIF · Traditional | Essential Dental Systems | 02/12/2021SE |
| K201222 | Bio-C Repair Ion+KIF · Traditional | Angelus Industria DE Produtos Odontologicos S/A | 02/11/2021SE |
| K200174 | Dia-Root Bio MtaKIF · Traditional | DiaDent Group International | 09/18/2020SE |
| K200175 | DIA-ROOT BIO SealerKIF · Traditional | DiaDent Group International | 06/25/2020SE |
| K190091 | DiapasteKIF · Traditional | DiaDent Group International | 03/27/2020SE |
| K190537 | BIO-C Sealer Ion+KIF · Abbreviated | Angelus Industria DE Produtos Odontologicos S/A | 12/12/2019SE |
| K182009 | Dia-ProsealKIF · Traditional | DiaDent Group International | 09/26/2019SE |
| K190503 | CeraSealKIF · Traditional | Meta Biomed Co., Ltd. | 06/07/2019SE |
| K182625 | Diapex PlusKIF · Traditional | DiaDent Group International | 06/03/2019SE |
| K190510 | GuttaSilKIF · Traditional | Meta Biomed Co., Ltd. | 05/29/2019SE |
| K181917 | MTA2.3 MaterialsKIF · Traditional | NuSmile, Ltd. | 01/11/2019SE |
| K180199 | Bio-C TempKIF · Traditional | Angelus Industria DE Produtos Odontologicos S/A | 01/04/2019SE |
| K181922 | Sonendo Material AKIF · Traditional | Sonendo, Inc. | 10/22/2018SE |
| K180185 | Bio-C RepairKIF · Traditional | Angelus Industria DE Produtos Odontologicos S/A | 08/31/2018SE |
| K170175 | Endoseal MtaKIF · Traditional | Maruchi | 02/26/2018SE |
| K172839 | EndosolvKIF · Traditional | Septodont | 02/13/2018SE |
| K172701 | Bio-C SealerKIF · Traditional | Angelus Industria DE Produtos Odontologicos S/A | 01/04/2018SE |
| K170950 | Well-Root STKIF · Traditional | Vericom Co., Ltd. | 12/20/2017SE |
| K170207 | ObturysKIF · Abbreviated | Itena Clinical | 07/31/2017SE |
| K162661 | SavDenTM MTA Root Canal Filling MaterialsKIF · Traditional | Tyds Biotech Incorporation | 04/25/2017SE |
| K161239 | MTA2.2 MaterialKIF · Traditional | Avalon Biomed, Inc. | 09/01/2016SE |
| K151047 | MTA Repair HPKIF · Traditional | Angelus Industria DE Productos Odontologicos | 08/31/2016SE |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | Sybron Dental Specialties | 07/27/2016SE |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTKIF · Traditional | Sybron Dental Specialties | 05/06/2016SE |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | Sybron Dental Specialties | 04/14/2016SE |
| K142178 | Proroot Mta White, Proroot Mta GrayKIF · Traditional | Dentsply International, Inc. | 02/26/2015SE |
| K130312 | Iroot FMKIF · Traditional | Innovative Bioceramix, Inc. | 09/18/2014SE |
| K140132 | BiodentineKIF · Traditional | Septodont | 06/27/2014SE |
| K140955 | MTA2.1 MaterialKIF · Special | Avalon Biomed, Inc. | 06/11/2014SE |
| K133054 | EndosealKIF · Traditional | Maruchi | 05/12/2014SE |
| K133042 | Endocem ZRKIF · Traditional | Maruchi | 05/12/2014SE |
| K140247 | Mta FillapexKIF · Special | Angelus Industria DE Productos Odontologicos SA | 04/25/2014SE |
| K132825 | Retromta-Orthomta IIKIF · Traditional | Biomta | 04/10/2014SE |
| K133716 | Trc-PasteKIF · Traditional | Km Corporation | 04/09/2014SE |
| K132123 | Trc-Pex, Radic-SealerKIF · Traditional | Km Corporation | 03/20/2014SE |
| K123276 | Mm-SealKIF · Traditional | Micro-Mega Societe Anonyme | 03/10/2014SE |
| K130601 | Bioroot RCSKIF · Abbreviated | Novocol, Inc. | 10/17/2013SE |
| K130125 | Mta CementsKIF · Traditional | S&C Polymer Silicon- Und Composite Spezialitaeten | 07/24/2013SE |
| K122892 | MTA2 Root and Pulp MaterialsKIF · Traditional | Avalon Biomed, Inc. | 12/11/2012SE |
| K113568 | Mta-FillapexKIF · Traditional | Paxmed International | 08/21/2012SE |
| K120048 | DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SKIF · Traditional | Drfp , Ltd. | 06/20/2012SE |
| K112078 | Endocem Mta (Mineral Trioxide Aggregate)KIF · Traditional | Maruchi | 03/19/2012SE |
| K112046 | Mta AngelusKIF · Traditional | Angelus Industria DE Productos Odontologicos | 01/06/2012SE |
| K102867 | Iroot FSKIF · Special | Innovative Bioceramix, Inc. | 12/03/2010SE |
| K102575 | Ortho Mta (Mineral Trioxide Aggregate)KIF · Traditional | Do Co., Ltd. | 10/29/2010SE |
| K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SKIF · Traditional | Drfp , Ltd. | 10/22/2010SE |
| K102163 | Realseal XT SealerKIF · Traditional | Kerr Corporation | 10/16/2010SE |
| K093208 | SimplisealKIF · Traditional | Discus Dental, LLC | 02/12/2010SE |
| K092251 | BiodentineKIF · Traditional | Septodont | 10/30/2009SE |
| K092715 | Iroot BP PlusKIF · Special | Innovative Bioceramix, Inc. | 09/28/2009SE |
| K090992 | Well-PasteKIF · Traditional | Vericom Co., Ltd. | 04/21/2009SE |
| K083062 | Root Canal XRKIF · Traditional | S & C Polymer GmbH | 03/12/2009SE |
| K082943 | Iroot BP, Model Irbp 4609KIF · Traditional | Innovative Bioceramix, Inc. | 01/06/2009SE |
| K080917 | Iroot SPKIF · Traditional | Innovative Bioceramix, Inc. | 04/09/2008SE |
| K080203 | Mta Root Canal SealerKIF · Traditional | Dentsply Interntional | 03/26/2008SE |
| K080266 | Well-PexKIF · Traditional | Vericom Co., Ltd. | 02/06/2008SE |
| K073218 | Mta Advanced MaterialKIF · Traditional | Dentsply Interntional | 01/07/2008SE |
| K071106 | Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill)…KIF · Special | Ultradent Products, Inc. | 05/08/2007SE |
| K063856 | Ez-Fill Xpress Epoxy Root Canal Cement SystemKIF · Traditional | Essential Dental Systems, Inc. | 02/06/2007SE |
| K063422 | BioaggregateKIF · Traditional | Innovative Bioceramix, Inc. | 11/21/2006SE |
| K060889 | Se Epiphany Root Canal Sealant, Model N59SEKIF · Traditional | Pentron Clinical Technologies | 10/27/2006SE |
| K060946 | CZ-S2000KIF · Traditional | Parkell, Inc. | 06/15/2006SE |
| K042769 | Adseal Root Canal SealerKIF · Traditional | Meta Biomed Co., Ltd. | 11/24/2004SE |
| K042756 | EndorezKIF · Special | Ultradent Products, Inc. | 10/26/2004SE |
| K033585 | DiapexKIF · Traditional | Bisco, Inc. | 01/16/2004SE |
| K032662 | GuttaflowKIF · Traditional | Coltene/Whaledent GmbH & Co. KG | 11/03/2003SE |
| K032605 | Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal FillingKIF · Traditional | Meta Biomed Co., Ltd. | 10/08/2003SE |
| K032603 | Metapex Calcium Hydroxide with Lodoform Temporary Root Canal FillingKIF · Traditional | Meta Biomed Co., Ltd. | 10/07/2003SE |
| K023818 | Fiberfill AgpKIF · Traditional | Pentron Clinical Technologies | 04/03/2003SE |
| K023976 | Acroseal Root Canal or Apical SealerKIF · Traditional | Septodont S.A.S. | 01/30/2003SE |
| K022734 | Pulpdent Calcium Hydroxide PreparationKIF · Traditional | Pulpdent Corporation | 10/07/2002SE |
| K011748 | First Fill R.C.S.KIF · Traditional | Jeneric/Pentron, Inc. | 08/03/2001SE |
| K010940 | Sealapex 4KIF · Traditional | Sybron Dental Specialties, Inc. | 06/20/2001SE |
| K011009 | White Mta MaterialKIF · Traditional | Dentsply International | 05/02/2001SE |
| K992727 | The Bi-Directional Spiral & Epoxy Root Canal Cement SystemKIF · Traditional | Mds | 01/18/2000SE |
| K992097 | EndorezKIF · Traditional | Ultradent Products, Inc. | 10/26/1999SE |
| K983037 | Roeko SealKIF · Traditional | Roeko Ulm, Roescheisen GmbH & Co. | 10/20/1998SE |
| K981620 | Mta Material IIKIF · Traditional | Dentsply Intl. | 07/31/1998SE |
| K980633 | Endosolv EKIF · Traditional | Specialites Septodont | 05/01/1998SE |
| K980332 | Mta MaterialKIF · Traditional | Dentsply Intl. | 02/24/1998SE |
| K973667 | Vitapex Pre-Loaded Dental SyringeKIF · Traditional | Neodental Chemical Products Co., Ltd. | 11/06/1997SE |
| K972369 | SealapexKIF · Traditional | Sybron Dental Specialties, Inc. | 08/15/1997SE |
| K971899 | Endo-SealKIF · Traditional | Ultradent Products, Inc. | 06/26/1997SE |
| K971622 | Max-I-Probe Endodontic Sealer Delivery SystemKIF · Traditional | Mpl Technologies, Inc. | 06/20/1997SE |
| K964174 | Mineral Trioxide Aggregate (Mta)KIF · Traditional | Tulsa Dental Products, Ltd. | 02/10/1997SE |
| K963922 | Alpha-Dent Root Canal Sealer & FillerKIF · Traditional | Wallace A. Erickson & Co. | 12/06/1996SE |
| K962885 | Sealex Extra Root Canal SealerKIF · Traditional | Baladent | 08/30/1996SE |
| K955703 | Neo Dental Endodontic Irrigation SyringeKIF · Traditional | Neodental Chemical Products Co., Ltd. | 05/20/1996SE |
| K960548 | Ah Plus Root Canal SealerKIF · Traditional | Dentsply Intl. | 04/26/1996SE |
| K946138 | Pulpdent Root Canal SealerKIF · Traditional | Pulpdent Corp. | 01/20/1995SE |
| K940368 | Canal King (Thin) Canal King (Thick)KIF · Traditional | Pulpdent Corp. | 01/20/1995SE |
| K942393 | Tubli-Seal EwtKIF · Traditional | Sybron Dental Specialties, Inc. | 06/10/1994SE |
| K930872 | Alpha-Dent Root Canal Sealer; Wach's FormulaKIF · Traditional | Wallace A. Erickson & Co. | 02/01/1994SE |
| K932791 | Pulpdent Edta PreparationsKIF · Traditional | Pulpdent Corp. | 09/20/1993SE |
| K914325 | Root Canal Filling CementKIF · Traditional | Confi-Dental Products Co. | 03/09/1992SE |
| K896657 | Root Canal Sealer, Modified Grossmans' FormulaKIF · Traditional | Pulpdent Corp. | 02/14/1990SE |
| K896656 | Root Canal Sealer, Groosmans' Formula BismuthKIF · Traditional | Pulpdent Corp. | 02/14/1990SE |
| K894092 | Dental Endodontic Cement (Modification)KIF · Traditional | The Hygenic Corp. | 01/10/1990SE |
| K893794 | Apexit Root Canal SealerKIF · Traditional | Williams Dental Co., Inc. | 11/29/1989SE |
| K854253 | Root Canal Filling ResinKIF · Traditional | Dentsply Intl. | 12/16/1985SE |
| K844635 | Hydroset Root Canal SealerKIF · Traditional | Lund Manufacturing Co. | 02/19/1985SE |
| K830763 | FR Root Canal FillerKIF · Traditional | Shizai Corp. | 08/26/1983SE |
| K820284 | Root Canal Filling ResinKIF · Traditional | Dentsply Intl. | 03/19/1982SE |
| K810923 | Lee Endofill, Root Canal Filling ResinKIF · Traditional | Lee Pharmaceuticals | 04/21/1981SE |
| K801482 | Hydron Root Canal Filling MaterialKIF · Traditional | National Patent Development Corp. | 07/21/1980SE |
| K771921 | Hydron Root Canal Filling SystemKIF · Traditional | National Patent Development Corp. | 11/15/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2836-2016 Class II | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root…SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of… | Ormco/Sybronendo | 08/31/2016Terminated |
| Z-0917-2010 | Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by…Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in… | Sybron Dental Specialties | 02/23/2009Terminated |