510(k) K172452
K172452 is an FDA 510(k) premarket notification submitted by Sleep Specialties, LLC for the device "Bruxor". The FDA issued a decision of Substantially Equivalent on Jan 11, 2018. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2018
- Date Received
- Aug 14, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Over-The-Counter
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.