Prosthetic devices · 21 CFR 872 Subpart D
Root Canal Filling Resin
FDA device type “Resin, Root Canal Filling”.
- Companies listing it
- 6839 makers
- Brands and models
- 212
- 510(k) clearances
- 14833 in five years
- FDA name
- Resin, Root Canal Filling
510(k) clearances per year, 1976–2026
Companies that list KIF
68 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | ProRoot MTA · ProRoot MTA Matl (root repair) · ProRoot MTA, Tooth Colored Formula · Root Canal Lube | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Paste · BLSEAL · BLSEAL Putty · CanalPro CalciSeal · +3 | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | VioSeal · Vioseal X | 22 | 2026 |
| Voco GmbH | Germany | Maker | MTA vpt | 117 | 2026 |
| DiaDent Group International | South Korea | Maker | DIA-PROSEAL · DIA-ROOT BIO MTA · DIA-ROOT BIO Sealer · DiaPaste · +1 | 24 | 2026 |
| GC America Inc. | United States | Maker | Nogenol Root Canal Sealer | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Pulp Canal Sealer · Pulp Canal Sealer EWT · Sealapex · Sealapex Xpress · +7 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | EndoREZ Accelerator · EndoREZ Dual Cure · EndoREZ Obturation Kit · MTApex Bioceramic Root Canal Sealer · +1 | 95 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | MTA1 | 23 | 2025 |
| Prevest Denpro Limited | India | Maker | CalApex · Calplus · Cerafill RCS · Endoseal · +3 | 7 | 2024 |
| Inter-Med, Inc. | United States | Maker | RE-GEN Bioactive Endosealer · REGEN Bioactive EndoPutty · Vista-Cal | 7 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | ADSEAL · ADSEAL Plus · CeraPutty · CeraSeal · +6 | 24 | 2024 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Calcium Hydroxide Temporary Filling Material (KP-Cal ) · Injectable Root Canal Sealer (KP-Root SP) | 3 | 2026 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | Well-Paste · Well-Pex | 20 | 2026 |
| Innovative Bioceramix, Inc. | Canada | Maker | EdgeBioceramic RetroFill and Perforation Repair Material .5g · EdgeBioceramic Sealer 2g · EdgeBioceramic ThermalFlow 1.5g · EndoSequence BC Pediatric Putty .5g 1P · +18 | 8 | 2023 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | C-Root BP · Injectable Root Canal Bioceramic Sealer | 2 | 2024 |
| Enpuno Biotechnology Co., Ltd | China | Maker | Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5 · Root canal repair materials (nRoot BP) | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Dental Endodontic Cement Mod. · MM-SEAL | 45 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | BioSeal · EZ-Fill Bi-Directional Spiral · EZ-Fill Cement · EZ-Fill Root Canal Cement · +1 | 15 | 2023 |
| Maruchi | South Korea | Maker | AH Plus® Bioceramic Sealer · CleaniCal · ENDOCEM MTA · ENDOCEM MTA PREMIXED REGULAR · +6 | 8 | 2023 |
| NuSmile, Ltd. | United States | Maker | Avalon Biomed Grey MTA Plus · Avalon Biomed NeoMTA 2 · Avalon Biomed NeoMTA Plus · Avalon Biomed NeoPUTTY · +9 | 2 | 2026 |
| Odne AG | Switzerland | Maker | OdneFill | 1 | 2024 |
| Sprig Oral Health Technologies, Inc. | United States | Maker | SmartMTA Capsule | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | Forendo · Pulpdent Root Canal Sealer Kit · Pulpdent Root Canal Sealer Liquid · Pulpdent Root Canal Sealer Powder | 107 | 2021 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Septodont | France | Maker | — | 17 | 2021 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | BIO-C REPAIR · BIO-C REPAIR ION+ · Bio-C Sealer · BIO-C SEALER ION+ · +6 | 11 | 2021 |
| ITENA Clinical | France | Maker | RESIN, ROOT CANAL FILLING | 8 | 2017 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | Root Canal Medicament · Vitapex | 5 | 2011 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Cal | 2 | 2013 |
| Temrex Corp. | United States | Maker | DOC'S BEST RED / DOC'S BEST WHITE CANAL SEALER | 2 | 2012 |
| COLTENE Holding AG | Switzerland | Maker | CanalPro CalciSeal · ROEKO GuttaFlow · ROEKO GuttaFlow 2 | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET BioRepair · KOMET BioSeal · KometSeal | 1 | 2007 |
| BioMTA | South Korea | Maker | OrthoMTA(Mineral Trioxide Aggregate) · RetroMTA-OrthoMTA II · Smart MTA | 1 | 2014 |
| B.J.M. Laboratories Ltd | Israel | Maker | BJM Root Canal Sealer · Obturys | — | — |
| Produits Dentaires SA | Switzerland | Maker | OdneFill · PD MTA White | — | — |
| Aadi Med Private Limited | India | Maker | Calahyd-RC (1.5g x 2 syr) · Calcium Hydroxide powder (15g, 30g, 100g) · Calx-O (1.5gm x 2 syr.) · Ceraseal-B (1g + 5ml) · +4 | — | — |
| Viarden Lab LLC | United States | Maker | ENDODONTIC CEMENT VIARDEN LAB, MTA, CPE-R | — | — |
| DSI Dental Solutions Ltd | Israel | Manufacturer | ApexSil RC · ApexSil Silver · ReMTA One · ZOER RC Automix | 2 | 2025 |
| B&L Biotech Co., Ltd. | South Korea | Manufacturer | Well-Paste | 1 | 2006 |
| Directa AB | Sweden | Contract manufacturer | SendoCem MTA · SendoSeal MTA | 1 | 2015 |
| Engineered Endodontics | United States | Repacker / relabeler | — | 1 | 2019 |
| SS White Burs LLC | United States | Manufacturer | SS White Bioceramic Root Canal Sealer | 1 | 2008 |
| Jersey Dental Supplies | United States | Repacker / relabeler | Adseal · AH PLUS ROOT CANAL SEALER · Apexit Root Canal Sealer · METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING · +4 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | AH Plus · dental cement | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | BIO-C SEALER ION+ · Bioactive Endosealer · Calcium Hydroxide · Patterson MTA Cement · +1 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | AH Plus · dental cement · dental resin | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeBioCeramic RetroFill and Perforation Repair · EdgeBioCeramic Sealer · EdgeBioCeramic ThermalFlow Sealer · EdgeUtopia Bioceramic Sealer · +1 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | AH Plus / 26 · Pulp Canal / EWT · Sealapex · Tubliseal / EWT | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIA-PROSEAL · DIA-ROOT BIO MTA · DIA-ROOT BIO Sealer · DiaPaste · +1 | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | AdSeal Root Canal Sealer · Metapaste Calcium Hydroxide With Barium · Metapex Calcium Hydroxide With Lodoform · SimpliSeal | — | — |
| Bina Limited | Belize | Foreign exporter | root canal filling · TIPS IRRIGATION MTA | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Root Canal Sealer | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Novocol Pharmaceutical of Canada, Inc. | Canada | Foreign exporter | Biodentine | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Sure Dent Corporation | South Korea | Manufacturer | Sure-Paste · Sure-Seal Root | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | EndoCeramic Root Repair Material | — | — |
| Shanghai Jpy Ion-Tech Co., Ltd. | China | Contract sterilizer | PINNACLE GRIPTION | — | — |
| Digital Arches Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Oct 2026 | K262478 | BCS Bioceramic Sealer | BCS Device Pte., Ltd. |
| 11 Sep 2026 | K262050 | Vioseal X | Spident Co., Ltd. |
| 4 Sep 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. |
| 25 Aug 2026 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. |
| 29 Jun 2026 | K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. |
| 12 Jan 2026 | K253167 | Any-Paste | Mediclus Co., Ltd |
| 7 Jan 2026 | K252890 | ZenSeal Pro | Sybron Dental Specialties |
| 25 Sep 2025 | K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd |
| 19 Sep 2025 | K252285 | Well-Root PT | Vericom Co., Ltd. |
| 22 Aug 2025 | K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd |
| 3 Jul 2025 | K251390 | MTA vpt | Voco GmbH |
| 11 Jun 2025 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. |
| 14 Mar 2025 | K243353 | One-Fil Putty | Mediclus Co., Ltd |
| 13 Feb 2025 | K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. |
| 12 Dec 2024 | K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. |
| 7 Nov 2024 | K242702 | VioSeal | Spident Co., Ltd. |
| 3 Oct 2024 | K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. |
| 28 Aug 2024 | K241457 | Vista BC Putty | Inter-Med, Inc. |
| 30 Jul 2024 | K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products |
| 28 May 2024 | K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd |
| 10 May 2024 | K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., LTD. |
| 26 Jan 2024 | K232182 | One-Fil | Mediclus Co., Ltd |
| 29 Sep 2023 | K232299 | CeraPutty | Meta Biomed Co, Ltd |
| 28 Jul 2023 | K231480 | Bright MTA Sealer Plus | GENOSS Co., Ltd. |
| 10 Jul 2023 | K231387 | Endofill | Lumendo AG |
| 31 May 2023 | K231259 | iRoot SP Plus | Innovative Bioceramix, Inc. |
| 13 Apr 2023 | K230010 | ADSEAL Plus | Meta Biomed Co, Ltd |
| 24 Mar 2023 | K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. |
| 14 Feb 2023 | K213757 | Endocem MTA Premixed Regular | Maruchi |
| 22 Nov 2022 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | Innovative Bioceramix, Inc. |
| 21 Nov 2022 | K221811 | Vista BC Sealer | Inter-Med, Inc. |
| 23 May 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited |
| 8 Dec 2021 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., LTD. |
| 13 Oct 2021 | K211905 | UltraCal XS | Ultradent Products, Inc. |
| 16 Sep 2021 | K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont |
| 27 Aug 2021 | K211995 | Sonendo Filling Material 5C | Sonendo, Inc. |
| 13 Aug 2021 | K212229 | White Endoseal MTA | Maruchi |
| 10 Aug 2021 | K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont |
| 30 Jun 2021 | K210904 | Metapaste Plus | Meta Biomed Co, Ltd |
| 14 Apr 2021 | K202617 | Metapex Plus | Meta Biomed Co, Ltd |
| 25 Mar 2021 | K210333 | DiaPaste | DiaDent Group International |
| 24 Mar 2021 | K202015 | White ENDOSEAL MTA | Maruchi |
| 12 Feb 2021 | K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems, Inc. |
| 11 Feb 2021 | K201222 | Bio-C Repair Ion+ | Angelus Industria DE Produtos Odontologicos S/A |
| 18 Sep 2020 | K200174 | DIA-ROOT BIO MTA | DiaDent Group International |
| 25 Jun 2020 | K200175 | DIA-ROOT BIO Sealer | DiaDent Group International |
| 27 Mar 2020 | K190091 | Diapaste | DiaDent Group International |
| 12 Dec 2019 | K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A |
| 26 Sep 2019 | K182009 | Dia-Proseal | DiaDent Group International |
| 7 Jun 2019 | K190503 | CeraSeal | Meta Biomed Co, Ltd |
| 3 Jun 2019 | K182625 | Diapex Plus | DiaDent Group International |
| 29 May 2019 | K190510 | GuttaSil | Meta Biomed Co, Ltd |
| 11 Jan 2019 | K181917 | MTA2.3 MATERIALS | NuSmile, Ltd. |
| 4 Jan 2019 | K180199 | BIO-C TEMP | Angelus Industria DE Produtos Odontologicos S/A |
| 22 Oct 2018 | K181922 | Sonendo Material A | Sonendo, Inc. |
| 31 Aug 2018 | K180185 | BIO-C REPAIR | Angelus Industria DE Produtos Odontologicos S/A |
| 26 Feb 2018 | K170175 | ENDOSEAL MTA | Maruchi |
| 13 Feb 2018 | K172839 | ENDOSOLV | Septodont |
| 4 Jan 2018 | K172701 | BIO-C SEALER | Angelus Industria DE Produtos Odontologicos S/A |
| 20 Dec 2017 | K170950 | Well-Root ST | Vericom Co., Ltd. |
| 31 Jul 2017 | K170207 | Obturys | ITENA Clinical |
| 25 Apr 2017 | K162661 | SavDenTM MTA Root Canal Filling Materials | Tyds Biotech Incorporation |
| 1 Sep 2016 | K161239 | MTA2.2 MATERIAL | Avalon Biomed, Inc. |
| 31 Aug 2016 | K151047 | MTA Repair HP | Angelus Industria DE Produtos Odontologicos S/A |
| 27 Jul 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | Sybron Dental Specialties |
| 6 May 2016 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | Sybron Dental Specialties |
| 14 Apr 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Sybron Dental Specialties |
| 26 Feb 2015 | K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Dentsply International, Inc. |
| 18 Sep 2014 | K130312 | IROOT FM | Innovative Bioceramix, Inc. |
| 27 Jun 2014 | K140132 | BIODENTINE | Septodont |
| 11 Jun 2014 | K140955 | MTA2.1 MATERIAL | Avalon Biomed, Inc. |
| 12 May 2014 | K133054 | ENDOSEAL | Maruchi |
| 12 May 2014 | K133042 | ENDOCEM ZR | Maruchi |
| 25 Apr 2014 | K140247 | MTA FILLAPEX | Angelus Industria DE Produtos Odontologicos S/A |
| 10 Apr 2014 | K132825 | RETROMTA-ORTHOMTA II | BioMTA |
| 9 Apr 2014 | K133716 | TRC-PASTE | Km Corporation |
| 20 Mar 2014 | K132123 | TRC-PEX, RADIC-SEALER | Km Corporation |
| 10 Mar 2014 | K123276 | MM-SEAL | Micro-Mega Societe Anonyme |
| 17 Oct 2013 | K130601 | BIOROOT RCS | Novocol, Inc. |
| 24 Jul 2013 | K130125 | MTA CEMENTS | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH |
| 11 Dec 2012 | K122892 | MTA2 ROOT AND PULP MATERIALS | Avalon Biomed, Inc. |
| 21 Aug 2012 | K113568 | MTA-FILLAPEX | Paxmed International |
| 20 Jun 2012 | K120048 | DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S | Drfp , Ltd. |
| 19 Mar 2012 | K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | Maruchi |
| 6 Jan 2012 | K112046 | MTA ANGELUS | Angelus Industria DE Produtos Odontologicos S/A |
| 3 Dec 2010 | K102867 | IROOT FS | Innovative Bioceramix, Inc. |
| 29 Oct 2010 | K102575 | ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) | Do Co., Ltd. |
| 22 Oct 2010 | K100248 | DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S | Drfp , Ltd. |
| 16 Oct 2010 | K102163 | REALSEAL XT SEALER | Sybron Dental Specialties |
| 12 Feb 2010 | K093208 | SIMPLISEAL | Philips Medical Systems International BV |
| 30 Oct 2009 | K092251 | BIODENTINE | Septodont |
| 28 Sep 2009 | K092715 | IROOT BP PLUS | Innovative Bioceramix, Inc. |
| 21 Apr 2009 | K090992 | WELL-PASTE | Vericom Co., Ltd. |
| 12 Mar 2009 | K083062 | ROOT CANAL XR | S & C Polymer GmbH |
| 6 Jan 2009 | K082943 | IROOT BP, MODEL IRBP 4609 | Innovative Bioceramix, Inc. |
| 9 Apr 2008 | K080917 | IROOT SP | Innovative Bioceramix, Inc. |
| 26 Mar 2008 | K080203 | MTA ROOT CANAL SEALER | Dentsply Interntional |
| 6 Feb 2008 | K080266 | WELL-PEX | Vericom Co., Ltd. |
| 7 Jan 2008 | K073218 | MTA ADVANCED MATERIAL | Dentsply Interntional |
| 8 May 2007 | K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | Ultradent Products, Inc. |
| 6 Feb 2007 | K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | Essential Dental Systems, Inc. |
| 21 Nov 2006 | K063422 | BIOAGGREGATE | Innovative Bioceramix, Inc. |
| 27 Oct 2006 | K060889 | SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE | Pentron Clinical Technologies |
| 15 Jun 2006 | K060946 | CZ-S2000 | Parkell, Inc |
| 24 Nov 2004 | K042769 | ADSEAL ROOT CANAL SEALER | Meta Biomed Co, Ltd |
| 26 Oct 2004 | K042756 | ENDOREZ | Ultradent Products, Inc. |
| 16 Jan 2004 | K033585 | DIAPEX | Bisco, Inc. |
| 3 Nov 2003 | K032662 | GUTTAFLOW | COLTENE Holding AG |
| 8 Oct 2003 | K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING | Meta Biomed Co, Ltd |
| 7 Oct 2003 | K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING | Meta Biomed Co, Ltd |
| 3 Apr 2003 | K023818 | FIBERFILL AGP | Pentron Clinical Technologies |
| 30 Jan 2003 | K023976 | ACROSEAL ROOT CANAL OR APICAL SEALER | Septodont |
| 7 Oct 2002 | K022734 | PULPDENT CALCIUM HYDROXIDE PREPARATION | Pulpdent Corporation |
| 3 Aug 2001 | K011748 | FIRST FILL R.C.S. | Jeneric/Pentron, Inc. |
| 20 Jun 2001 | K010940 | SEALAPEX 4 | Sybron Dental Specialties |
| 2 May 2001 | K011009 | WHITE MTA MATERIAL | Dentsply International, Inc. |
| 18 Jan 2000 | K992727 | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM | Mds |
| 26 Oct 1999 | K992097 | ENDOREZ | Ultradent Products, Inc. |
| 20 Oct 1998 | K983037 | ROEKO SEAL | Roeko Ulm, Roescheisen GmbH & Co. |
| 31 Jul 1998 | K981620 | MTA MATERIAL II | Dentsply Intl., Inc. |
| 1 May 1998 | K980633 | ENDOSOLV E | Specialites Septodont |
| 24 Feb 1998 | K980332 | MTA MATERIAL | Dentsply Intl., Inc. |
| 6 Nov 1997 | K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | Neodental Chemical Products Co., Ltd. |
| 15 Aug 1997 | K972369 | SEALAPEX | Sybron Dental Specialties |
| 26 Jun 1997 | K971899 | ENDO-SEAL | Ultradent Products, Inc. |
| 20 Jun 1997 | K971622 | MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM | Mpl Technologies, Inc. |
| 10 Feb 1997 | K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | Dentsply Sirona, Inc. |
| 6 Dec 1996 | K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | Wallace A. Erickson & Co. |
| 30 Aug 1996 | K962885 | SEALEX EXTRA ROOT CANAL SEALER | Baladent |
| 20 May 1996 | K955703 | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | Neodental Chemical Products Co., Ltd. |
| 26 Apr 1996 | K960548 | AH PLUS ROOT CANAL SEALER | Dentsply Intl., Inc. |
| 20 Jan 1995 | K946138 | PULPDENT ROOT CANAL SEALER | Pulpdent Corporation |
| 20 Jan 1995 | K940368 | CANAL KING (THIN) CANAL KING (THICK) | Pulpdent Corporation |
| 10 Jun 1994 | K942393 | TUBLI-SEAL EWT | Sybron Dental Specialties |
| 1 Feb 1994 | K930872 | ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA | Wallace A. Erickson & Co. |
| 20 Sep 1993 | K932791 | PULPDENT EDTA PREPARATIONS | Pulpdent Corporation |
| 9 Mar 1992 | K914325 | ROOT CANAL FILLING CEMENT | Confi-Dental Products Co. |
| 14 Feb 1990 | K896657 | ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA | Pulpdent Corporation |
| 14 Feb 1990 | K896656 | ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH | Pulpdent Corporation |
| 10 Jan 1990 | K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | The Hygenic Company, LLC |
| 29 Nov 1989 | K893794 | APEXIT ROOT CANAL SEALER | Williams Dental Co., Inc. |
| 16 Dec 1985 | K854253 | ROOT CANAL FILLING RESIN | Dentsply Intl., Inc. |
| 19 Feb 1985 | K844635 | HYDROSET ROOT CANAL SEALER | Lund Manufacturing Co. |
| 26 Aug 1983 | K830763 | FR ROOT CANAL FILLER | Shizai Corp. |
| 19 Mar 1982 | K820284 | ROOT CANAL FILLING RESIN | Dentsply Intl., Inc. |
| 21 Apr 1981 | K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN | Lee Pharmaceuticals |
| 21 Jul 1980 | K801482 | HYDRON ROOT CANAL FILLING MATERIAL | National Patent Development Corp. |
| 15 Nov 1977 | K771921 | HYDRON ROOT CANAL FILLING SYSTEM | National Patent Development Corp. |
Official records: FDA product classification for KIF · 21 CFR 872.3820.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026