K220816 is an FDA 510(k) clearance for the BruxZir NOW. 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 August 2, 2022, 134 days after receiving the submission on March 21, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K220816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2022 |
| Decision Date | August 02, 2022 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |