K203499 is an FDA 510(k) clearance for the Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Vatech Acucera, Inc. (Yongin-Si, KR). The FDA issued a Cleared decision on April 5, 2021, 129 days after receiving the submission on November 27, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K203499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2020 |
| Decision Date | April 05, 2021 |
| Days to Decision | 129 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 |