The following data is part of a premarket notification filed by Pro3dure Medical Gmbh with the FDA for Gr-14 Resin System.
| Device ID | K210298 |
| 510k Number | K210298 |
| Device Name: | GR-14 Resin System |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Pro3dure Medical GmbH Am Burgberg 13 Iserlohn, DE 58642 |
| Contact | Frank Gischer |
| Correspondent | Patricia Kontoudis Regulatory And Quality Solutions, LLC 2790 Mosside Blvd., Suite 800 Monroeville, PA 15146 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-03 |
| Decision Date | 2021-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPRCD1001313 | K210298 | 000 |
| EPRCD1001301 | K210298 | 000 |
| EPRCD1001315 | K210298 | 000 |
| EPRCD1001314 | K210298 | 000 |
| EPRCD1001302 | K210298 | 000 |
| EPRCD1001303 | K210298 | 000 |
| EPRCD1001304 | K210298 | 000 |
| EPRCD1001311 | K210298 | 000 |
| EPRCD1001312 | K210298 | 000 |
| EPRCD1001319 | K210298 | 000 |