510(k) K172452
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2018
- Date Received
- August 14, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Over-The-Counter
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.