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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K090169
Device Name SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
Applicant
Air Techniques, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact NATALYA VALERIO
Correspondent
Air Techniques, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact NATALYA VALERIO
Regulation Number872.1745
Classification Product Code
NBL  
Date Received01/23/2009
Decision Date 08/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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