K011675 is an FDA 510(k) clearance for the THE AUTOTAC SYSTEM. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on June 22, 2001, 23 days after receiving the submission on May 30, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K011675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2001 |
| Decision Date | June 22, 2001 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |