K181157 is an FDA 510(k) clearance for the Conical Plus Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Osseofuse International, Inc. (Calabasas, US). The FDA issued a Cleared decision on May 24, 2019, 388 days after receiving the submission on May 1, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K181157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2018 |
| Decision Date | May 24, 2019 |
| Days to Decision | 388 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 |