510(k) K222845
K222845 is an FDA 510(k) premarket notification submitted by Frey Oral Technologies, LLC for the device "Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece". The FDA issued a decision of Substantially Equivalent on November 28, 2023. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2023
- Date Received
- September 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type