The following data is part of a premarket notification filed by Pro3dure Medical Gmbh with the FDA for Gr Splint Resin System.
| Device ID | K211415 |
| 510k Number | K211415 |
| Device Name: | GR Splint Resin System |
| Classification | Mouthguard, Prescription |
| Applicant | Pro3dure Medical GmbH Am Burgberg 13 Iserlohn, DE 58642 |
| Contact | Frank Gischer |
| Correspondent | Patricia Kontoudis Regulatory And Quality Solutions, LLC 2790 Mosside Blvd. Monroeville, PA 15146 |
| Product Code | MQC |
| Subsequent Product Code | EBI |
| Subsequent Product Code | KMY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPRCD1001702 | K211415 | 000 |
| EPRCD1001610 | K211415 | 000 |
| EPRCD1001611 | K211415 | 000 |
| EPRCD1001703 | K211415 | 000 |
| EPRCD1001704 | K211415 | 000 |
| EPRCD1000800 | K211415 | 000 |
| EPRCD1000801 | K211415 | 000 |
| EPRCD1001491 | K211415 | 000 |
| EPRCD1001492 | K211415 | 000 |
| EPRCD1001493 | K211415 | 000 |
| EPRCD1001701 | K211415 | 000 |
| EPRCD1001609 | K211415 | 000 |