FDA 510(k) Application Details - K051909

Device Classification Name Laser,Fluorescence Caries Detection

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510(K) Number K051909
Device Name Laser,Fluorescence Caries Detection
Applicant KAVO AMERICA
PO BOX 7007
DEER FIELD, IL 60015 US
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Contact DENIEL KAMM
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Regulation Number 872.1745

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Classification Product Code NBL
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Date Received 07/14/2005
Decision Date 10/21/2005
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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