510(k) K172223
K172223 is an FDA 510(k) premarket notification submitted by Splintek, Inc. for the device "SleepRight ProRx Custom Dental Guard". The FDA issued a decision of Substantially Equivalent on Nov 17, 2017. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Splintek, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 17, 2017
- Date Received
- Jul 24, 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.