K071638 is an FDA 510(k) clearance for the BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by BioHorizons Implant Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on October 10, 2007, 117 days after receiving the submission on June 15, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K071638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2007 |
| Decision Date | October 10, 2007 |
| Days to Decision | 117 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 |