510(k) K091792
K091792 is an FDA 510(k) premarket notification submitted by Ranir Corporation for the device "REST ASSURED GENERATION II DENTAL PROTECTOR". The FDA issued a decision of Substantially Equivalent on July 8, 2009. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2009
- Date Received
- June 17, 2009
- Clearance Type
- Special
- 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.