K231347 is an FDA 510(k) clearance for the BruxZir™ TintEFX Coloring Liquid. 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 June 9, 2023, 31 days after receiving the submission on May 9, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K231347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2023 |
| Decision Date | June 09, 2023 |
| Days to Decision | 31 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 |