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FDA 510(k) Application Details - K062961
Device Classification Name
Caries Detector, Laser Light, Transmission
More FDA Info for this Device
510(K) Number
K062961
Device Name
Caries Detector, Laser Light, Transmission
Applicant
ADDENT, INC.
43 MIRY BROOK RD.
DANBURY, CT 06810 US
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Contact
JOSHUA FRIEDMAN
Other 510(k) Applications for this Contact
Regulation Number
872.1745
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Classification Product Code
NTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2006
Decision Date
02/08/2007
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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