The following data is part of a premarket notification filed by Pro3dure Medical Gmbh with the FDA for Thermeo System.
| Device ID | K212017 |
| 510k Number | K212017 |
| Device Name: | Thermeo System |
| Classification | Mouthguard, Prescription |
| Applicant | Pro3dure Medical GmbH Am Burgberg 13 Iserlohn, DE 58642 |
| Contact | Frank Gischer |
| Correspondent | Frank Gischer Pro3dure Medical GmbH Am Burgberg 13 Iserlohn, DE 58642 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPRCD1022003 | K212017 | 000 |
| 01111111111116 | K212017 | 000 |
| 01111111111123 | K212017 | 000 |
| EPRCD1010119 | K212017 | 000 |
| EPRCD1010120 | K212017 | 000 |
| EPRCD1010121 | K212017 | 000 |
| EPRCD1010122 | K212017 | 000 |
| EPRCD1010123 | K212017 | 000 |
| EPRCD1010124 | K212017 | 000 |
| EPRCD1010125 | K212017 | 000 |
| EPRCD1010126 | K212017 | 000 |
| EPRCD1010127 | K212017 | 000 |
| EPRCD1022002 | K212017 | 000 |
| EPRCD1022006 | K212017 | 000 |