K212259 is an FDA 510(k) clearance for the Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Zirdent New Material Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on November 12, 2021, 115 days after receiving the submission on July 20, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K212259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2021 |
| Decision Date | November 12, 2021 |
| Days to Decision | 115 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 |