510(k) K212448
K212448 is an FDA 510(k) premarket notification submitted by Sprintray, Inc. for the device "NightGuard Flex". The FDA issued a decision of Substantially Equivalent on November 12, 2021. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Sprintray, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2021
- Date Received
- August 5, 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