K210523 is an FDA 510(k) clearance for the Implanova. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Dental Evolutions, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on September 30, 2021, 219 days after receiving the submission on February 23, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K210523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2021 |
| Decision Date | September 30, 2021 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |