FDA 510(k) Application Details - K090169

Device Classification Name Laser,Fluorescence Caries Detection

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510(K) Number K090169
Device Name Laser,Fluorescence Caries Detection
Applicant AIR TECHNIQUES, INC.
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact NATALYA VALERIO
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Regulation Number 872.1745

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Classification Product Code NBL
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Date Received 01/23/2009
Decision Date 08/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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