K192535 is an FDA 510(k) clearance for the Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Qinhuangdao Audental Metal Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on January 31, 2020, 137 days after receiving the submission on September 16, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K192535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2019 |
| Decision Date | January 31, 2020 |
| Days to Decision | 137 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 |