K201563 is an FDA 510(k) clearance for the PuRE PMMA Disc. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Quest Dental USA Corp. (Irvine, US). The FDA issued a Cleared decision on April 9, 2021, 303 days after receiving the submission on June 10, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K201563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2020 |
| Decision Date | April 09, 2021 |
| Days to Decision | 303 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |