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FDA 510(k) Application Details - K123402
Device Classification Name
Caries Detector, Laser Light, Transmission
More FDA Info for this Device
510(K) Number
K123402
Device Name
Caries Detector, Laser Light, Transmission
Applicant
KALTENBACH & VOIGT GMBH
BISMARCHRING 39
BIBERACH / RISS 88400 DE
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Contact
STEFAN TRAMPLER
Other 510(k) Applications for this Contact
Regulation Number
872.1745
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Classification Product Code
NTK
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More FDA Info for this Product Code
Date Received
11/05/2012
Decision Date
09/24/2013
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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