Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece— 510(k) K222845
Substantially EquivalentFrey Oral Technologies, LLC
FDA 510(k) clearance K222845 for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece, Substantially Equivalent on 2023-11-28. Applicant: Frey Oral Technologies, LLC.
Clearance details
- Applicant
- Frey Oral Technologies, LLC
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly Hills, CA, US
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.