510(k) K062828
K062828 is an FDA 510(k) premarket notification submitted by Dentsply Intl., Inc. for the device "MOUTHGUARD AND ALIGNER MATERIALS". The FDA issued a decision of Substantially Equivalent on November 27, 2006. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Dentsply Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2006
- Date Received
- September 20, 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