K130924 is an FDA 510(k) clearance for the BRUXZIR SHADED. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on May 16, 2013, 43 days after receiving the submission on April 3, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K130924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2013 |
| Decision Date | May 16, 2013 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |