FDA 510(k) Application Details - K123402

Device Classification Name Caries Detector, Laser Light, Transmission

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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
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Regulation Number 872.1745

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Classification Product Code NTK
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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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