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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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