K201827 is an FDA 510(k) clearance for the GR-17 Resin System. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Pro3dure Medical GmbH (Iserlohn, DE). The FDA issued a Cleared decision on November 5, 2020, 126 days after receiving the submission on July 2, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K201827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2020 |
| Decision Date | November 05, 2020 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| 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 |