510(k) K241311
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) by
Bernhard Förster GmbH
— Product Code MQC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2024
- Date Received
- May 9, 2024
- 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