K240672 is an FDA 510(k) clearance for the Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML). This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Zhejiang Zahndent Biotechnology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on June 7, 2024, 88 days after receiving the submission on March 11, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K240672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2024 |
| Decision Date | June 07, 2024 |
| Days to Decision | 88 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 |