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510(k) K090598

CARIESCAN PRO by Cariescan , Ltd. — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2009
Date Received
March 5, 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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