K233081 is an FDA 510(k) clearance for the NUVENTUS NV.C™ Dental Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Infinitum Eta, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on November 15, 2024, 416 days after receiving the submission on September 26, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K233081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | November 15, 2024 |
| Days to Decision | 416 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 |