510(k) K181361
K181361 is an FDA 510(k) premarket notification submitted by Brux Night Guard for the device "Brux Night Guard". The FDA issued a decision of Substantially Equivalent on Apr 11, 2019. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 11, 2019
- Date Received
- May 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)