510(k) K024261
K024261 is an FDA 510(k) premarket notification submitted by Dental Concepts, LLC for the device "DENTAL PROTECTOR". The FDA issued a decision of Substantially Equivalent on March 26, 2003. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Dental Concepts, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2003
- Date Received
- December 23, 2002
- 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