Resin, Root Canal Filling
Regulation 872.3820
7510(k)s in 12 months (148 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KIF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K262478 | BCS Bioceramic Sealer BCS Device Pte., Ltd., SG | KIF |
| Sep 11, 2026 | K262050 | Vioseal X Spident Co., Ltd., KR | KIF |
| Sep 4, 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste NuSmile, Ltd. | KIF |
| Aug 25, 2026 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) Guilin Kevin Peter Technology Co., Ltd., CN | KIF |
| Jun 29, 2026 | K261415 | Injectable Root Canal Sealer (KP-Root SP) Guilin Kevin Peter Technology Co., Ltd., CN | KIF |
| Jan 12, 2026 | K253167 | Any-Paste Mediclus Co., Ltd., KR | KIF |
| Jan 7, 2026 | K252890 | ZenSeal Pro Kerr Corporation | KIF |
| Sep 25, 2025 | K251465 | Root canal repair materials (nRoot BP) Enpuno Biotechnology Co., Ltd., CN | KIF |
| Sep 19, 2025 | K252285 | Well-Root PT Vericom Co., Ltd., KR | KIF |
| Aug 22, 2025 | K251884 | One-Fil Putty Injectable Mediclus Co., Ltd., KR | KIF |
| Jul 3, 2025 | K251390 | MTA vpt Voco GmbH, DE | KIF |
| Jun 11, 2025 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) Enpuno Co., Ltd., CN | KIF |
| Mar 14, 2025 | K243353 | One-Fil Putty Mediclus Co., Ltd., KR | KIF |
| Feb 13, 2025 | K243546 | AH Plus Endodontic Sealer Dentsply Sirona, Inc. | KIF |
| Dec 12, 2024 | K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) Longly Biotechnology (Wuhan) Co., Ltd., CN | KIF |
| Nov 7, 2024 | K242702 | VioSeal Spident Co., Ltd., KR | KIF |
| Oct 3, 2024 | K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) Longly Biotechnology (Wuhan) Co., Ltd., CN | KIF |
| Aug 28, 2024 | K241457 | Vista BC Putty Inter-Med, Inc. | KIF |
| Jul 30, 2024 | K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + Shiva Products, IN | KIF |
| May 28, 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., CN | KIF |
| May 10, 2024 | K240365 | Bioceramic Root Repair Material (C-Root BP) Beijing C-Root Dental Medical Devices Co., Ltd., CN | KIF |
| Jan 26, 2024 | K232182 | One-Fil Mediclus Co., Ltd., KR | KIF |
| Sep 29, 2023 | K232299 | CeraPutty Meta Biomed Co., Ltd., KR | KIF |
| Jul 28, 2023 | K231480 | Bright MTA Sealer Plus Genoss Co., Ltd., KR | KIF |
| Jul 10, 2023 | K231387 | Endofill Lumendo AG, CH | KIF |
| May 31, 2023 | K231259 | iRoot SP Plus Innovative Bioceramix, Inc., CA | KIF |
| Apr 13, 2023 | K230010 | ADSEAL Plus Meta Biomed Co., Ltd., KR | KIF |
| Mar 24, 2023 | K230797 | SmartMTA Capsule Sprig Oral Health Technologies, Inc. | KIF |
| Feb 14, 2023 | K213757 | Endocem MTA Premixed Regular Maruchi, KR | KIF |
| Nov 22, 2022 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Mater Innovative Bioceramix, Inc., CA | KIF |
| Nov 21, 2022 | K221811 | Vista BC Sealer Inter-Med, Inc. | KIF |
| May 23, 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid Prevest Denpro Limited, IN | KIF |
| Dec 8, 2021 | K212983 | Injectable Root Canal Bioceramic Sealer Beijing C-Root Dental Medical Devices Co., Ltd., CN | KIF |
| Oct 13, 2021 | K211905 | UltraCal XS Ultradent Products, Inc. | KIF |
| Sep 16, 2021 | K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g Septodont, FR | KIF |
| Aug 27, 2021 | K211995 | Sonendo Filling Material 5C Sonendo, Inc. | KIF |
| Aug 13, 2021 | K212229 | White Endoseal MTA Maruchi, KR | KIF |
| Aug 10, 2021 | K211799 | Biodentine XP 500, Biodentine XP 200 Septodont, FR | KIF |
| Jun 30, 2021 | K210904 | Metapaste Plus Meta Biomed Co., Ltd., KR | KIF |
| Apr 14, 2021 | K202617 | Metapex Plus Meta Biomed Co., Ltd., KR | KIF |
| Mar 25, 2021 | K210333 | DiaPaste DiaDent Group International, KR | KIF |
| Mar 24, 2021 | K202015 | White ENDOSEAL MTA Maruchi, KR | KIF |
| Feb 12, 2021 | K202281 | EDS Bioceramic Sealer (Bioseal) Essential Dental Systems | KIF |
| Feb 11, 2021 | K201222 | Bio-C Repair Ion+ Angelus Industria DE Produtos Odontologicos S/A, BR | KIF |
| Sep 18, 2020 | K200174 | DIA-ROOT BIO MTA DiaDent Group International, KR | KIF |
| Jun 25, 2020 | K200175 | DIA-ROOT BIO Sealer DiaDent Group International, KR | KIF |
| Mar 27, 2020 | K190091 | Diapaste DiaDent Group International, KR | KIF |
| Dec 12, 2019 | K190537 | BIO-C Sealer Ion+ Angelus Industria DE Produtos Odontologicos S/A, BR | KIF |
| Sep 26, 2019 | K182009 | Dia-Proseal DiaDent Group International, KR | KIF |
| Jun 7, 2019 | K190503 | CeraSeal Meta Biomed Co., Ltd., KR | KIF |
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