510(k) K090169
K090169 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "SPECTRA FLUORESCENCE CARIES DETECTION DEVICE". The FDA issued a decision of Substantially Equivalent on August 18, 2009. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2009
- Date Received
- January 23, 2009
- 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