KIF — Resin, Root Canal Filling Class II
FDA product code KIF covers "Resin, Root Canal Filling", a Class II medical device regulated under 21 CFR 872.3820. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KIF
- Device Class
- Class II
- Regulation Number
- 872.3820
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261415 | guilin kevin peter technology co | Injectable Root Canal Sealer (KP-Root SP) | June 29, 2026 |
| K253167 | mediclus co | Any-Paste | January 12, 2026 |
| K252890 | kerr corporation | ZenSeal Pro | January 7, 2026 |
| K251465 | enpuno biotechnology co | Root canal repair materials (nRoot BP) | September 25, 2025 |
| K252285 | vericom co | Well-Root PT | September 19, 2025 |
| K251884 | mediclus co | One-Fil Putty Injectable | August 22, 2025 |
| K251390 | voco | MTA vpt | July 3, 2025 |
| K250710 | enpuno co | Injectable Root Canal Bioceramic Sealer (nRoot SP) | June 11, 2025 |
| K243353 | mediclus co | One-Fil Putty | March 14, 2025 |
| K243546 | dentsply sirona | AH Plus Endodontic Sealer | February 13, 2025 |
| K242934 | longly biotechnology (wuhan) co | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | December 12, 2024 |
| K242702 | spident co | VioSeal | November 7, 2024 |
| K241977 | longly biotechnology (wuhan) co | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | October 3, 2024 |
| K241457 | inter-med | Vista BC Putty | August 28, 2024 |
| K240446 | shiva products | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax | July 30, 2024 |
| K240304 | enpuno biotechnology co | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, N | May 28, 2024 |
| K240365 | beijing c-root dental medical devices co | Bioceramic Root Repair Material (C-Root BP) | May 10, 2024 |
| K232182 | mediclus co | One-Fil | January 26, 2024 |
| K232299 | meta biomed co | CeraPutty | September 29, 2023 |
| K231480 | genoss co | Bright MTA Sealer Plus | July 28, 2023 |