K013236 is an FDA 510(k) clearance for the LUXABITE. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on October 17, 2001, 19 days after receiving the submission on September 28, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K013236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2001 |
| Decision Date | October 17, 2001 |
| Days to Decision | 19 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |