K083432 is an FDA 510(k) clearance for the DRILL FREE MMF SCREW. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 31, 2009, 131 days after receiving the submission on November 20, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K083432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2008 |
| Decision Date | March 31, 2009 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| 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 |