K181266 is an FDA 510(k) clearance for the Implantswiss Dental Implant System, Implantswiss Dental Abutment System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Novodent SA (Yverdons-Les-Bains, CH). The FDA issued a Cleared decision on November 1, 2018, 171 days after receiving the submission on May 14, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K181266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2018 |
| Decision Date | November 01, 2018 |
| Days to Decision | 171 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 |