K141724 is an FDA 510(k) clearance for the UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Liaoning Upcera Co., Ltd. (New Milford, US). The FDA issued a Cleared decision on October 22, 2014, 118 days after receiving the submission on June 26, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K141724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2014 |
| Decision Date | October 22, 2014 |
| Days to Decision | 118 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 |