510(k) K133037
K133037 is an FDA 510(k) premarket notification submitted by Grind Guard Technologies, LLC for the device "GRINDGUARD". The FDA issued a decision of Substantially Equivalent on Jan 23, 2014. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Grind Guard Technologies, LLC has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2014
- Date Received
- Sep 26, 2013
- 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.