510(k) K202974
K202974 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "DenTek Fresh Protect Dental Guard". The FDA issued a decision of Substantially Equivalent on December 22, 2020. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2020
- Date Received
- September 30, 2020
- 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.