K240586 is an FDA 510(k) clearance for the Additive Manufacturing Zirconia Customized Restoration. This device is classified as a Teeth, Porcelain (Class II - Special Controls, product code ELL).
Submitted by Hangzhou Thales Medtech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 3, 2024, 216 days after receiving the submission on March 1, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K240586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2024 |
| Decision Date | October 03, 2024 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELL - Teeth, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3920 |