K230487 is an FDA 510(k) clearance for the Dental Lithium Disilicate Glass-Ceramic. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Fuzhou Rick Brown Biomaterials Co., Ltd. (Fuzhou, CN). The FDA issued a Cleared decision on July 3, 2023, 130 days after receiving the submission on February 23, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K230487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2023 |
| Decision Date | July 03, 2023 |
| Days to Decision | 130 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 |