510(k) K183315
K183315 is an FDA 510(k) premarket notification submitted by Dental Choice Holdings, LLC for the device "CustMBite Dental Guard". The FDA issued a decision of Substantially Equivalent on August 23, 2019. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Dental Choice Holdings, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2019
- Date Received
- November 30, 2018
- 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.