K003883 is an FDA 510(k) clearance for the MOLINA ORBITAL MALAR DISTRACTOR. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on January 23, 2001, 39 days after receiving the submission on December 15, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K003883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2000 |
| Decision Date | January 23, 2001 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |