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FDA 510(k) Application Details - K994368
Device Classification Name
Device, Caries Detection
More FDA Info for this Device
510(K) Number
K994368
Device Name
Device, Caries Detection
Applicant
AMERICAN DENTAL PRODUCTS, INC.
603-B COUNTRY CLUB DR.
BENSENVILLE, IL 60106-1329 US
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Contact
GEORGE NICOLAE
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Regulation Number
872.1740
More FDA Info for this Regulation Number
Classification Product Code
LFC
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More FDA Info for this Product Code
Date Received
12/27/1999
Decision Date
03/14/2000
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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