510(k) K063483
K063483 is an FDA 510(k) premarket notification submitted by Den Tek Oral Care, Inc. for the device "DEN TEK NIGHTGUARD". The FDA issued a decision of Substantially Equivalent on January 23, 2007. The device falls under product code MQC (Mouthguard, Prescription), 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
- January 23, 2007
- Date Received
- November 17, 2006
- 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