K180365 is an FDA 510(k) clearance for the PRAMA White Implant Systems. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Sweden & Martina S.P.A. (Due Carrare, IT). The FDA issued a Cleared decision on July 8, 2019, 511 days after receiving the submission on February 12, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K180365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2018 |
| Decision Date | July 08, 2019 |
| Days to Decision | 511 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 |