FDA Product Code
FDA Product Code KIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3820
510(k) Clearances — 147 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262050 | Vioseal X | Spident Co., Ltd. | 2026-09-11 | Traditional | PDF ↗ |
| K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | 2026-09-04 | Traditional | PDF ↗ |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | 2026-08-25 | Traditional | PDF ↗ |
| K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | 2026-06-29 | Traditional | PDF ↗ |
| K253167 | Any-Paste | Mediclus Co., Ltd. | 2026-01-12 | Traditional | PDF ↗ |
| K252890 | ZenSeal Pro | Kerr Corporation | 2026-01-07 | Traditional | PDF ↗ |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | 2025-09-25 | Traditional | PDF ↗ |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 2025-09-19 | Traditional | PDF ↗ |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025-08-22 | Special | PDF ↗ |
| K251390 | MTA vpt | Voco GmbH | 2025-07-03 | Traditional | PDF ↗ |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | 2025-06-11 | Traditional | PDF ↗ |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025-03-14 | Traditional | PDF ↗ |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | 2025-02-13 | Traditional | PDF ↗ |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-12-12 | Traditional | PDF ↗ |
| K242702 | VioSeal | Spident Co., Ltd. | 2024-11-07 | Traditional | PDF ↗ |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-10-03 | Traditional | PDF ↗ |
| K241457 | Vista BC Putty | Inter-Med, Inc. | 2024-08-28 | Traditional | PDF ↗ |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | 2024-07-30 | Traditional | PDF ↗ |
| 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. | 2024-05-28 | Traditional | PDF ↗ |
| K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K232182 | One-Fil | Mediclus Co., Ltd. | 2024-01-26 | Traditional | PDF ↗ |
| K232299 | CeraPutty | Meta Biomed Co., Ltd. | 2023-09-29 | Traditional | PDF ↗ |
| K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | 2023-07-28 | Traditional | PDF ↗ |
| K231387 | Endofill | Lumendo AG | 2023-07-10 | Traditional | PDF ↗ |
| K231259 | iRoot SP Plus | Innovative Bioceramix, Inc. | 2023-05-31 | Special | PDF ↗ |
| K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | 2023-04-13 | Traditional | PDF ↗ |
| K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | 2023-03-24 | Traditional | PDF ↗ |
| K213757 | Endocem MTA Premixed Regular | Maruchi | 2023-02-14 | Traditional | PDF ↗ |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | Innovative Bioceramix, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K221811 | Vista BC Sealer | Inter-Med, Inc. | 2022-11-21 | Traditional | PDF ↗ |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | 2022-05-23 | Traditional | PDF ↗ |
| K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021-12-08 | Traditional | PDF ↗ |
| K211905 | UltraCal XS | Ultradent Products, Inc. | 2021-10-13 | Traditional | PDF ↗ |
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont | 2021-09-16 | Traditional | PDF ↗ |
| K211995 | Sonendo Filling Material 5C | Sonendo, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K212229 | White Endoseal MTA | Maruchi | 2021-08-13 | Special | PDF ↗ |
| K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont | 2021-08-10 | Traditional | PDF ↗ |
| K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | 2021-06-30 | Traditional | PDF ↗ |
| K202617 | Metapex Plus | Meta Biomed Co., Ltd. | 2021-04-14 | Traditional | PDF ↗ |
| K210333 | DiaPaste | DiaDent Group International | 2021-03-25 | Special | PDF ↗ |
| K202015 | White ENDOSEAL MTA | Maruchi | 2021-03-24 | Traditional | PDF ↗ |
| K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | 2021-02-12 | Traditional | PDF ↗ |
| K201222 | Bio-C Repair Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2021-02-11 | Traditional | PDF ↗ |
| K200174 | DIA-ROOT BIO MTA | DiaDent Group International | 2020-09-18 | Traditional | PDF ↗ |
| K200175 | DIA-ROOT BIO Sealer | DiaDent Group International | 2020-06-25 | Traditional | PDF ↗ |
| K190091 | Diapaste | DiaDent Group International | 2020-03-27 | Traditional | PDF ↗ |
| K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2019-12-12 | Abbreviated | PDF ↗ |
| K182009 | Dia-Proseal | DiaDent Group International | 2019-09-26 | Traditional | PDF ↗ |
| K190503 | CeraSeal | Meta Biomed Co., Ltd. | 2019-06-07 | Traditional | PDF ↗ |
| K182625 | Diapex Plus | DiaDent Group International | 2019-06-03 | Traditional | PDF ↗ |
| K190510 | GuttaSil | Meta Biomed Co., Ltd. | 2019-05-29 | Traditional | PDF ↗ |
| K181917 | MTA2.3 MATERIALS | NuSmile, Ltd. | 2019-01-11 | Traditional | PDF ↗ |
| K180199 | BIO-C TEMP | Angelus Industria DE Produtos Odontologicos S/A | 2019-01-04 | Traditional | PDF ↗ |
| K181922 | Sonendo Material A | Sonendo, Inc. | 2018-10-22 | Traditional | PDF ↗ |
| K180185 | BIO-C REPAIR | Angelus Industria DE Produtos Odontologicos S/A | 2018-08-31 | Traditional | PDF ↗ |
| K170175 | ENDOSEAL MTA | Maruchi | 2018-02-26 | Traditional | PDF ↗ |
| K172839 | ENDOSOLV | Septodont | 2018-02-13 | Traditional | PDF ↗ |
| K172701 | BIO-C SEALER | Angelus Industria DE Produtos Odontologicos S/A | 2018-01-04 | Traditional | PDF ↗ |
| K170950 | Well-Root ST | Vericom Co., Ltd. | 2017-12-20 | Traditional | PDF ↗ |
| K170207 | Obturys | Itena Clinical | 2017-07-31 | Abbreviated | PDF ↗ |
| K162661 | SavDenTM MTA Root Canal Filling Materials | Tyds Biotech Incorporation | 2017-04-25 | Traditional | PDF ↗ |
| K161239 | MTA2.2 MATERIAL | Avalon Biomed, Inc. | 2016-09-01 | Traditional | PDF ↗ |
| K151047 | MTA Repair HP | Angelus Industria DE Productos Odontologicos | 2016-08-31 | Traditional | PDF ↗ |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | Sybron Dental Specialties | 2016-07-27 | Traditional | PDF ↗ |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | Sybron Dental Specialties | 2016-05-06 | Traditional | PDF ↗ |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Sybron Dental Specialties | 2016-04-14 | Special | PDF ↗ |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Dentsply International, Inc. | 2015-02-26 | Traditional | PDF ↗ |
| K130312 | IROOT FM | Innovative Bioceramix, Inc. | 2014-09-18 | Traditional | PDF ↗ |
| K140132 | BIODENTINE | Septodont | 2014-06-27 | Traditional | PDF ↗ |
| K140955 | MTA2.1 MATERIAL | Avalon Biomed, Inc. | 2014-06-11 | Special | PDF ↗ |
| K133054 | ENDOSEAL | Maruchi | 2014-05-12 | Traditional | PDF ↗ |
| K133042 | ENDOCEM ZR | Maruchi | 2014-05-12 | Traditional | PDF ↗ |
| K140247 | MTA FILLAPEX | Angelus Industria DE Productos Odontologicos SA | 2014-04-25 | Special | PDF ↗ |
| K132825 | RETROMTA-ORTHOMTA II | Biomta | 2014-04-10 | Traditional | PDF ↗ |
| K133716 | TRC-PASTE | Km Corporation | 2014-04-09 | Traditional | PDF ↗ |
| K132123 | TRC-PEX, RADIC-SEALER | Km Corporation | 2014-03-20 | Traditional | PDF ↗ |
| K123276 | MM-SEAL | Micro-Mega Societe Anonyme | 2014-03-10 | Traditional | PDF ↗ |
| K130601 | BIOROOT RCS | Novocol, Inc. | 2013-10-17 | Abbreviated | PDF ↗ |
| K130125 | MTA CEMENTS | S&C Polymer Silicon- Und Composite Spezialitaeten | 2013-07-24 | Traditional | PDF ↗ |
| K122892 | MTA2 ROOT AND PULP MATERIALS | Avalon Biomed, Inc. | 2012-12-11 | Traditional | PDF ↗ |
| K113568 | MTA-FILLAPEX | Paxmed International | 2012-08-21 | Traditional | PDF ↗ |
| K120048 | DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S | Drfp , Ltd. | 2012-06-20 | Traditional | PDF ↗ |
| K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | Maruchi | 2012-03-19 | Traditional | PDF ↗ |
| K112046 | MTA ANGELUS | Angelus Industria DE Productos Odontologicos | 2012-01-06 | Traditional | PDF ↗ |
| K102867 | IROOT FS | Innovative Bioceramix, Inc. | 2010-12-03 | Special | PDF ↗ |
| K102575 | ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) | Do Co., Ltd. | 2010-10-29 | Traditional | PDF ↗ |
| K100248 | DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S | Drfp , Ltd. | 2010-10-22 | Traditional | PDF ↗ |
| K102163 | REALSEAL XT SEALER | Kerr Corporation | 2010-10-16 | Traditional | PDF ↗ |
| K093208 | SIMPLISEAL | Discus Dental, LLC | 2010-02-12 | Traditional | PDF ↗ |
| K092251 | BIODENTINE | Septodont | 2009-10-30 | Traditional | PDF ↗ |
| K092715 | IROOT BP PLUS | Innovative Bioceramix, Inc. | 2009-09-28 | Special | PDF ↗ |
| K090992 | WELL-PASTE | Vericom Co., Ltd. | 2009-04-21 | Traditional | PDF ↗ |
| K083062 | ROOT CANAL XR | S & C Polymer GmbH | 2009-03-12 | Traditional | PDF ↗ |
| K082943 | IROOT BP, MODEL IRBP 4609 | Innovative Bioceramix, Inc. | 2009-01-06 | Traditional | PDF ↗ |
| K080917 | IROOT SP | Innovative Bioceramix, Inc. | 2008-04-09 | Traditional | PDF ↗ |
| K080203 | MTA ROOT CANAL SEALER | Dentsply Interntional | 2008-03-26 | Traditional | PDF ↗ |
| K080266 | WELL-PEX | Vericom Co., Ltd. | 2008-02-06 | Traditional | PDF ↗ |
| K073218 | MTA ADVANCED MATERIAL | Dentsply Interntional | 2008-01-07 | Traditional | PDF ↗ |
| K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | Ultradent Products, Inc. | 2007-05-08 | Special | PDF ↗ |
| K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | Essential Dental Systems, Inc. | 2007-02-06 | Traditional | PDF ↗ |
Product code KIF · Class II · Dental. Data: openFDA.