The following data is part of a premarket notification filed by Pro3dure Medical Gmbh with the FDA for Gr-17 Resin System.
| Device ID | K201827 |
| 510k Number | K201827 |
| Device Name: | GR-17 Resin System |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Pro3dure Medical GmbH Am Burgberg 13 Iserlohn, DE 58642 |
| Contact | Martin Klare |
| Correspondent | Patricia Kontoudis Regulatory And Quality Solutions, LLC 2790 Mosside Blvd., Suite 800 Monroeville, PA 15146 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPRCD1001630 | K201827 | 000 |
| EPRCD1001432 | K201827 | 000 |
| EPRCD1001433 | K201827 | 000 |
| EPRCD1001444 | K201827 | 000 |
| EPRCD1001445 | K201827 | 000 |
| EPRCD1001446 | K201827 | 000 |
| EPRCD1001615 | K201827 | 000 |
| EPRCD1001616 | K201827 | 000 |
| EPRCD1001619 | K201827 | 000 |
| EPRCD1001621 | K201827 | 000 |
| EPRCD1001627 | K201827 | 000 |
| EPRCD1001628 | K201827 | 000 |
| EPRCD1001629 | K201827 | 000 |
| EPRCD1001431 | K201827 | 000 |