510(k) K211158
K211158 is an FDA 510(k) premarket notification submitted by Boyd Research, Inc. for the device "NTI ClenchGuard". The FDA issued a decision of Substantially Equivalent on September 17, 2021. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Boyd Research, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2021
- Date Received
- April 19, 2021
- 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.