K053152 is an FDA 510(k) clearance for the BIOHORIZONS SINGLE-STAGE IMPLANT. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on December 2, 2005, 22 days after receiving the submission on November 10, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K053152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2005 |
| Decision Date | December 02, 2005 |
| Days to Decision | 22 days |
| Submission Type | Special |
| 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 |