K192231 is an FDA 510(k) clearance for the Dental Glass Ceramics Blocks. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Aidite (Qinhuangdao) Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on July 8, 2020, 327 days after receiving the submission on August 16, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K192231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2019 |
| Decision Date | July 08, 2020 |
| Days to Decision | 327 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 |