K200175 is an FDA 510(k) clearance for the DIA-ROOT BIO Sealer. 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 June 25, 2020, 154 days after receiving the submission on January 23, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K200175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2020 |
| Decision Date | June 25, 2020 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| 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 |