K072660 is an FDA 510(k) clearance for the ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on December 12, 2007, 82 days after receiving the submission on September 21, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K072660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2007 |
| Decision Date | December 12, 2007 |
| Days to Decision | 82 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 |