510(k) K081669
K081669 is an FDA 510(k) premarket notification submitted by Den Tek Oral Care, Inc. for the device "IMPROVED COMFORT-FIT NIGHTGUARD". The FDA issued a decision of Substantially Equivalent on July 10, 2008. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Den Tek Oral Care, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2008
- Date Received
- June 13, 2008
- Clearance Type
- Special
- 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.