K222520 is an FDA 510(k) clearance for the Zirconia Block. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Yilink (Tianjin) Biotechnology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on November 14, 2022, 87 days after receiving the submission on August 19, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K222520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2022 |
| Decision Date | November 14, 2022 |
| Days to Decision | 87 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 |