K203725 is an FDA 510(k) clearance for the S.I.N. Dental Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by S.I.N. ? Sistema DE Implante Nacional S.A. (Sao Paulo, BR). The FDA issued a Cleared decision on June 23, 2021, 184 days after receiving the submission on December 21, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K203725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2020 |
| Decision Date | June 23, 2021 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |