K091387 is an FDA 510(k) clearance for the BTI DENTAL IMPLANT 5.5-6.5. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by B.T.I. Biotechnology Institute, Sl. (Minano Menor, Alava, ES). The FDA issued a Cleared decision on January 22, 2010, 256 days after receiving the submission on May 11, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K091387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2009 |
| Decision Date | January 22, 2010 |
| Days to Decision | 256 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 |