Spectra Fluorescence Caries Detection Device
FDA 510(k) K090169 · Air Techniques, Inc.
510(k) numberK090169
Submission
- Device name
- Spectra Fluorescence Caries Detection Device
- Applicant
- Air Techniques, Inc.
Great Neck, NY, US - Received
- January 23, 2009
- Decision date
- August 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Spectra Fluorescence Caries Detection Device cleared by the FDA?
Spectra Fluorescence Caries Detection Device (K090169) received a 510(k) decision of Substantially Equivalent on August 18, 2009, 207 days after the submission was received.
What is the product code of K090169?
The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.