K190569 is an FDA 510(k) clearance for the Shaders ZR. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Digital Age Dental Lab (Redondo Beach, US). The FDA issued a Cleared decision on July 29, 2019, 145 days after receiving the submission on March 6, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K190569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2019 |
| Decision Date | July 29, 2019 |
| Days to Decision | 145 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 |