K241715 is an FDA 510(k) clearance for the Dental Glass Ceramics Blocks (HT,LT,ST). 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 12, 2024, 28 days after receiving the submission on June 14, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K241715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2024 |
| Decision Date | July 12, 2024 |
| Days to Decision | 28 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 |