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510(k) K123402

DIAGNOCAM by Kaltenbach & Voigt GmbH — Product Code NTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2013
Date Received
November 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caries Detector, Laser Light, Transmission
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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