K222845
- 510(k) number
- K222845
- Device name
- Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
- Applicant
- Frey Oral Technologies, LLC CA · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2023-11-28
- Date received
- 2022-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K222845.pdf
Official FDA record: K222845
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.