K191794 is an FDA 510(k) clearance for the Vintage Art Universal. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on October 3, 2019, 92 days after receiving the submission on July 3, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K191794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2019 |
| Decision Date | October 03, 2019 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |