510(k) K212767
K212767 is an FDA 510(k) premarket notification submitted by Splintek, Inc. for the device "SleepRight Select-Comfort Dental Guard". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Splintek, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2021
- Date Received
- August 31, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type