K240912 is an FDA 510(k) clearance for the Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro). This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Anhui Miisen Intelligence Technology Co., Ltd. (Wuhu, CN). The FDA issued a Cleared decision on May 31, 2024, 58 days after receiving the submission on April 3, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K240912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2024 |
| Decision Date | May 31, 2024 |
| Days to Decision | 58 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 |