Product code KIF
- Device name
- Resin, Root Canal Filling
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3820
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253167 | Any-Paste | Mediclus Co., Ltd. | 2026-01-12 |
| K252890 | ZenSeal Pro | Kerr Corporation | 2026-01-07 |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | 2025-09-25 |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 2025-09-19 |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025-08-22 |
| K251390 | MTA vpt | Voco GmbH | 2025-07-03 |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | 2025-06-11 |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025-03-14 |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | 2025-02-13 |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-12-12 |
| K242702 | VioSeal | Spident Co., Ltd. | 2024-11-07 |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-10-03 |
| K241457 | Vista BC Putty | Inter-Med, Inc. | 2024-08-28 |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | 2024-07-30 |
| 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 |
| K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2024-05-10 |
| K232182 | One-Fil | Mediclus Co., Ltd. | 2024-01-26 |
| K232299 | CeraPutty | Meta Biomed Co., Ltd. | 2023-09-29 |
| K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | 2023-07-28 |
| K231387 | Endofill | Lumendo AG | 2023-07-10 |
| K231259 | iRoot SP Plus | Innovative Bioceramix, Inc. | 2023-05-31 |
| K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | 2023-04-13 |
| K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | 2023-03-24 |
| K213757 | Endocem MTA Premixed Regular | Maruchi | 2023-02-14 |
| 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 |
| K221811 | Vista BC Sealer | Inter-Med, Inc. | 2022-11-21 |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | 2022-05-23 |
| K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021-12-08 |
| K211905 | UltraCal XS | Ultradent Products, Inc. | 2021-10-13 |
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont | 2021-09-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809518345106 | One-Fil Putty Injectable | MEDICLUS CO.,LTD | 2026-05-21 |
| 08809518341252 | One-Fil | MEDICLUS CO.,LTD | 2026-05-11 |
| 08809518343706 | One-Fil Putty | MEDICLUS CO.,LTD | 2026-05-11 |
| 08404535015126 | Brasseler USA | Peter Brasseler Holdings, LLC | 2026-04-29 |
| 08809518346608 | CanalPro CalciSeal | MEDICLUS CO.,LTD | 2026-04-23 |
| 08809262954371 | VioSeal | Spident Co., Ltd. | 2026-04-20 |
| 07898078652961 | BIO-C REPAIR | Angelus Industria de Produtos Odontologicos S A | 2026-03-25 |
| 07649988156618 | OdneFill | Odne AG | 2024-01-31 |
| 07615208008654 | Apexit Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-08-22 |
| 07898078659915 | BIO-C TEMP | Angelus Industria de Produtos Odontologicos S A | 2020-11-06 |
| 07898078658840 | BIO-C TEMP | Angelus Industria de Produtos Odontologicos S A | 2020-11-06 |
| 07898078658277 | MTA-FILLAPEX | Angelus Industria de Produtos Odontologicos S A | 2019-08-16 |
| 08806387893875 | GuttaSil | Meta Biomed Co., Ltd. | 2019-06-24 |
| 08806387894117 | GuttaSil Refill | Meta Biomed Co., Ltd. | 2019-06-24 |
| 08809254458146 | Well-Root ST | VERICOM CO., LTD. | 2018-10-18 |
| 08809254458139 | Well-Root ST | VERICOM CO., LTD. | 2018-10-18 |
| 08809254458115 | Well-Root ST | VERICOM CO., LTD. | 2018-10-18 |
| 10818207020205 | Vista-Cal Standard Kit | Vista Dental | 2018-07-31 |
| 08809254452304 | Well-Pex | VERICOM CO., LTD. | 2016-11-01 |
| 08809254452328 | Well-Paste | VERICOM CO., LTD. | 2016-11-01 |
| 08806383500166 | Diapaste | DiaDent Group International | 2016-10-04 |
| 08806383500159 | Diapaste | DiaDent Group International | 2016-10-04 |
| 08806383500142 | Diapaste | DiaDent Group International | 2016-10-04 |
| 08806383500135 | Diapaste | DiaDent Group International | 2016-10-04 |
| 08806383500128 | Diapaste | DiaDent Group International | 2016-10-04 |
| 08806383500111 | Diapex | DiaDent Group International | 2016-10-04 |
| 08806383500067 | Diapex | DiaDent Group International | 2016-10-04 |
| 08806383500050 | Diapex | DiaDent Group International | 2016-10-04 |
| J015206000360 | MM-SEAL | MICRO MEGA | 2016-09-22 |
| 07898078658260 | MTA-FILLAPEX | Angelus Industria de Produtos Odontologicos S A | 2016-08-19 |