K250811 is an FDA 510(k) clearance for the Dental Zirconia Ceramic. 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 April 11, 2025, 25 days after receiving the submission on March 17, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K250811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2025 |
| Decision Date | April 11, 2025 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |