510(k) K151933
K151933 is an FDA 510(k) premarket notification submitted by 12th Man Technologies, Inc. for the device "BRX PRO Bruxism Guard". The FDA issued a decision of Substantially Equivalent on December 10, 2015. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. 12th Man Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2015
- Date Received
- July 14, 2015
- 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