K222845 is an FDA 510(k) clearance for the Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece. This device is classified as a Mouthguard, Prescription.
Submitted by Frey Oral Technologies, LLC (Beverly Hills, US). The FDA issued a Cleared decision on November 28, 2023, 433 days after receiving the submission on September 21, 2022.
This device falls under the Dental FDA review panel.
| 510(k) Number | K222845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2022 |
| Decision Date | November 28, 2023 |
| Days to Decision | 433 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |