510(k) K112139
K112139 is an FDA 510(k) premarket notification submitted by Quantum Dental Technologies, Inc. for the device "THE CANARY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 26, 2012. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2012
- Date Received
- July 26, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type