K043226 is an FDA 510(k) clearance for the ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320. 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 January 13, 2005, 52 days after receiving the submission on November 22, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K043226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2004 |
| Decision Date | January 13, 2005 |
| Days to Decision | 52 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 |