K192510 is an FDA 510(k) clearance for the DIAFIL & DIAFIL Capsule. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on March 20, 2020, 190 days after receiving the submission on September 12, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K192510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2019 |
| Decision Date | March 20, 2020 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |