K092112 is an FDA 510(k) clearance for the BTI DENTAL IMPLANT TINY 2.5-3.0. 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 October 6, 2009, 84 days after receiving the submission on July 14, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K092112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2009 |
| Decision Date | October 06, 2009 |
| Days to Decision | 84 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 |