FDA 510(k) Applications for Medical Device Product Code "KIF"
(Resin, Root Canal Filling)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K112046 | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS | MTA ANGELUS | 01/06/2012 |
| K151047 | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS | MTA Repair HP | 08/31/2016 |
| K140247 | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA | MTA FILLAPEX | 04/25/2014 |
| K180185 | Angelus Industria de Produtos Odontologicos S/A | BIO-C REPAIR | 08/31/2018 |
| K201222 | Angelus Industria de Produtos Odontologicos S/A | Bio-C Repair Ion+ | 02/11/2021 |
| K172701 | Angelus Industria de Produtos Odontologicos S/A | BIO-C SEALER | 01/04/2018 |
| K190537 | Angelus Industria de Produtos Odontologicos S/A | BIO-C Sealer Ion+ | 12/12/2019 |
| K180199 | Angelus Industria de Produtos Odontologicos S/A | BIO-C TEMP | 01/04/2019 |
| K122892 | AVALON BIOMED INC. | MTA2 ROOT AND PULP MATERIALS | 12/11/2012 |
| K140955 | AVALON BIOMED INC. | MTA2.1 MATERIAL | 06/11/2014 |
| K161239 | AVALON BIOMED INC. | MTA2.2 MATERIAL | 09/01/2016 |
| K962885 | BALADENT | SEALEX EXTRA ROOT CANAL SEALER | 08/30/1996 |
| K212983 | Beijing C-Root Dental Medical Devices Co., LTD. | Injectable Root Canal Bioceramic Sealer | 12/08/2021 |
| K132825 | BIOMTA | RETROMTA-ORTHOMTA II | 04/10/2014 |
| K033585 | BISCO, INC. | DIAPEX | 01/16/2004 |
| K032662 | COLTENE/WHALEDENT GMBH & CO. KG | GUTTAFLOW | 11/03/2003 |
| K011009 | DENTSPLY INTERNATIONAL | WHITE MTA MATERIAL | 05/02/2001 |
| K142178 | DENTSPLY INTERNATIONAL INC. | PROROOT MTA WHITE, PROROOT MTA GRAY | 02/26/2015 |
| K073218 | DENTSPLY INTERNTIONAL | MTA ADVANCED MATERIAL | 01/07/2008 |
| K080203 | DENTSPLY INTERNTIONAL | MTA ROOT CANAL SEALER | 03/26/2008 |
| K960548 | DENTSPLY INTL. | AH PLUS ROOT CANAL SEALER | 04/26/1996 |
| K980332 | DENTSPLY INTL. | MTA MATERIAL | 02/24/1998 |
| K981620 | DENTSPLY INTL. | MTA MATERIAL II | 07/31/1998 |
| K182009 | Diadent Group International | Dia-Proseal | 09/26/2019 |
| K200174 | Diadent Group International | DIA-ROOT BIO MTA | 09/18/2020 |
| K200175 | Diadent Group International | DIA-ROOT BIO Sealer | 06/25/2020 |
| K210333 | Diadent Group International | DiaPaste | 03/25/2021 |
| K190091 | Diadent Group International | Diapaste | 03/27/2020 |
| K182625 | Diadent Group International | Diapex Plus | 06/03/2019 |
| K093208 | DISCUS DENTAL, LLC | SIMPLISEAL | 02/12/2010 |
| K102575 | DO CO., LTD. | ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) | 10/29/2010 |
| K100248 | DRFP LTD | DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S | 10/22/2010 |
| K120048 | DRFP LTD. | DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S | 06/20/2012 |
| K202281 | Essential Dental Systems | EDS Bioceramic Sealer (Bioseal) | 02/12/2021 |
| K063856 | ESSENTIAL DENTAL SYSTEMS, INC. | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | 02/06/2007 |
| K231480 | Genoss Co., Ltd. | Bright MTA Sealer Plus | 07/28/2023 |
| K063422 | INNOVATIVE BIOCERAMIX INC. | BIOAGGREGATE | 11/21/2006 |
| K092715 | INNOVATIVE BIOCERAMIX INC. | IROOT BP PLUS | 09/28/2009 |
| K222992 | Innovative BioCeramix Inc. | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | 11/22/2022 |
| K082943 | INNOVATIVE BIOCERAMIX INC. | IROOT BP, MODEL IRBP 4609 | 01/06/2009 |
| K130312 | INNOVATIVE BIOCERAMIX INC. | IROOT FM | 09/18/2014 |
| K102867 | INNOVATIVE BIOCERAMIX INC. | IROOT FS | 12/03/2010 |
| K080917 | INNOVATIVE BIOCERAMIX INC. | IROOT SP | 04/09/2008 |
| K231259 | Innovative BioCeramix, Inc. | iRoot SP Plus | 05/31/2023 |
| K221811 | Inter-Med, Inc. | Vista BC Sealer | 11/21/2022 |
| K170207 | Itena Clinical | Obturys | 07/31/2017 |
| K011748 | JENERIC/PENTRON, INC. | FIRST FILL R.C.S. | 08/03/2001 |
| K102163 | KERR CORPORATION | REALSEAL XT SEALER | 10/16/2010 |
| K133716 | KM CORPORATION | TRC-PASTE | 04/09/2014 |
| K132123 | KM CORPORATION | TRC-PEX, RADIC-SEALER | 03/20/2014 |
| K231387 | Lumendo AG | Endofill | 07/10/2023 |
| K112078 | MARUCHI | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | 03/19/2012 |
| K213757 | Maruchi | Endocem MTA Premixed Regular | 02/14/2023 |
| K133042 | MARUCHI | ENDOCEM ZR | 05/12/2014 |
| K133054 | MARUCHI | ENDOSEAL | 05/12/2014 |
| K170175 | MARUCHI | ENDOSEAL MTA | 02/26/2018 |
| K202015 | Maruchi | White ENDOSEAL MTA | 03/24/2021 |
| K212229 | MARUCHI | White Endoseal MTA | 08/13/2021 |
| K992727 | MDS | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM | 01/18/2000 |
| K230010 | Meta Biomed Co., LTD. | ADSEAL Plus | 04/13/2023 |
| K042769 | META BIOMED CO., LTD. | ADSEAL ROOT CANAL SEALER | 11/24/2004 |
| K232299 | Meta Biomed Co., Ltd. | CeraPutty | 09/29/2023 |
| K190503 | Meta Biomed Co., Ltd. | CeraSeal | 06/07/2019 |
| K190510 | Meta Biomed Co., Ltd. | GuttaSil | 05/29/2019 |
| K032605 | META BIOMED CO., LTD. | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING | 10/08/2003 |
| K210904 | Meta Biomed Co., Ltd. | Metapaste Plus | 06/30/2021 |
| K032603 | META BIOMED CO., LTD. | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING | 10/07/2003 |
| K202617 | Meta Biomed Co., Ltd. | Metapex Plus | 04/14/2021 |
| K123276 | MICRO-MEGA SOCIETE ANONYME | MM-SEAL | 03/10/2014 |
| K971622 | MPL TECHNOLOGIES, INC. | MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM | 06/20/1997 |
| K955703 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | 05/20/1996 |
| K973667 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. | VITAPEX PRE-LOADED DENTAL SYRINGE | 11/06/1997 |
| K130601 | NOVOCOL, INC. | BIOROOT RCS | 10/17/2013 |
| K181917 | NuSmile, LTD. | MTA2.3 MATERIALS | 01/11/2019 |
| K060946 | PARKELL, INC. | CZ-S2000 | 06/15/2006 |
| K113568 | PAXMED INTERNATIONAL | MTA-FILLAPEX | 08/21/2012 |
| K023818 | PENTRON CLINICAL TECHNOLOGIES | FIBERFILL AGP | 04/03/2003 |
| K060889 | PENTRON CLINICAL TECHNOLOGIES | SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE | 10/27/2006 |
| K212563 | Prevest Denpro Limited | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | 05/23/2022 |
| K022734 | PULPDENT CORPORATION | PULPDENT CALCIUM HYDROXIDE PREPARATION | 10/07/2002 |
| K983037 | ROEKO ULM, ROESCHEISEN GMBH & CO. | ROEKO SEAL | 10/20/1998 |
| K083062 | S & C POLYMER GMBH | ROOT CANAL XR | 03/12/2009 |
| K130125 | S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN | MTA CEMENTS | 07/24/2013 |
| K092251 | SEPTODONT | BIODENTINE | 10/30/2009 |
| K140132 | SEPTODONT | BIODENTINE | 06/27/2014 |
| K211799 | Septodont | Biodentine XP 500, Biodentine XP 200 | 08/10/2021 |
| K212283 | Septodont | BioRoot Flow 0.5g, BioRoot Flow 2g | 09/16/2021 |
| K172839 | Septodont | ENDOSOLV | 02/13/2018 |
| K023976 | SEPTODONT S.A.S. | ACROSEAL ROOT CANAL OR APICAL SEALER | 01/30/2003 |
| K211995 | Sonendo, Inc. | Sonendo Filling Material 5C | 08/27/2021 |
| K181922 | Sonendo, Inc. | Sonendo Material A | 10/22/2018 |
| K980633 | SPECIALITES SEPTODONT | ENDOSOLV E | 05/01/1998 |
| K230797 | Sprig Oral Health Technologies, Inc. | SmartMTA Capsule | 03/24/2023 |
| K152956 | SYBRON DENTAL SPECIALTIES | Pulp Canal Sealer, Pulp Canal Sealer EWT | 05/06/2016 |
| K152959 | Sybron Dental Specialties | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | 04/14/2016 |
| K153067 | SYBRON DENTAL SPECIALTIES | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | 07/27/2016 |
| K972369 | SYBRON DENTAL SPECIALTIES, INC. | SEALAPEX | 08/15/1997 |
| K010940 | SYBRON DENTAL SPECIALTIES, INC. | SEALAPEX 4 | 06/20/2001 |
| K964174 | TULSA DENTAL PRODUCTS, LTD. | MINERAL TRIOXIDE AGGREGATE (MTA) | 02/10/1997 |
| K162661 | tYDS Biotech Incorporation | SavDenTM MTA Root Canal Filling Materials | 04/25/2017 |
| K971899 | ULTRADENT PRODUCTS, INC. | ENDO-SEAL | 06/26/1997 |
| K042756 | ULTRADENT PRODUCTS, INC. | ENDOREZ | 10/26/2004 |
| K992097 | ULTRADENT PRODUCTS, INC. | ENDOREZ | 10/26/1999 |
| K071106 | ULTRADENT PRODUCTS, INC. | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | 05/08/2007 |
| K211905 | Ultradent Products, Inc. | UltraCal XS | 10/13/2021 |
| K090992 | VERICOM CO., LTD. | WELL-PASTE | 04/21/2009 |
| K080266 | VERICOM CO., LTD. | WELL-PEX | 02/06/2008 |
| K170950 | Vericom Co., Ltd. | Well-Root ST | 12/20/2017 |
| K963922 | WALLACE A. ERICKSON & CO. | ALPHA-DENT ROOT CANAL SEALER & FILLER | 12/06/1996 |
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