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510(k) K090169

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE by Air Techniques, Inc. — Product Code NBL

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
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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