FDA 510(k) Application Details - K994368

Device Classification Name Device, Caries Detection

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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

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Classification Product Code LFC
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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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