K210333 is an FDA 510(k) clearance for the DiaPaste. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on March 25, 2021, 48 days after receiving the submission on February 5, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K210333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2021 |
| Decision Date | March 25, 2021 |
| Days to Decision | 48 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KIF — Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |