KIF
- Product code
- KIF
- Device name
- Resin, Root Canal Filling
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3820
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 20
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 145 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261514 | 2026-08-25 | Guilin Kevin Peter Technology Co., Ltd… | Calcium Hydroxide Temporary Filling Material (KP-Cal… | |
| K261415 | 2026-06-29 | Guilin Kevin Peter Technology Co., Ltd… | Injectable Root Canal Sealer (KP-Root SP) | |
| K253167 | 2026-01-12 | Mediclus Co., Ltd. | Any-Paste | |
| K252890 | 2026-01-07 | Kerr Corporation | ZenSeal Pro | |
| K251465 | 2025-09-25 | Enpuno Biotechnology Co., Ltd. | Root canal repair materials (nRoot BP) | |
| K252285 | 2025-09-19 | Vericom Co., Ltd. | Well-Root PT | |
| K251884 | 2025-08-22 | Mediclus Co., Ltd. | One-Fil Putty Injectable | |
| K251390 | 2025-07-03 | Voco GmbH | MTA vpt | — |
| K250710 | 2025-06-11 | Enpuno Co., Ltd. | Injectable Root Canal Bioceramic Sealer (nRoot SP) | FDA |
| K243353 | 2025-03-14 | Mediclus Co., Ltd. | One-Fil Putty | |
| K243546 | 2025-02-13 | Dentsply Sirona, Inc. | AH Plus Endodontic Sealer | |
| K242934 | 2024-12-12 | Longly Biotechnology (Wuhan) Co., Ltd. | Bioceramic Root Canal Sealer and Repair Materials (i… | |
| K242702 | 2024-11-07 | Spident Co., Ltd. | VioSeal | |
| K241977 | 2024-10-03 | Longly Biotechnology (Wuhan) Co., Ltd. | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | FDA |
| K241457 | 2024-08-28 | Inter-Med, Inc. | Vista BC Putty | FDA |
| K240446 | 2024-07-30 | Shiva Products | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSe… | FDA |
| K240304 | 2024-05-28 | Enpuno Biotechnology Co., Ltd. | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, … | |
| K240365 | 2024-05-10 | Beijing C-Root Dental Medical Devices … | Bioceramic Root Repair Material (C-Root BP) | |
| K232182 | 2024-01-26 | Mediclus Co., Ltd. | One-Fil | |
| K232299 | 2023-09-29 | Meta Biomed Co., Ltd. | CeraPutty |
Official FDA classification page: KIF
Classification and pathway per current FDA publications. Data from openFDA (CC0).