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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K994368
Device Name AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
Applicant
AMERICAN DENTAL PRODUCTS, INC.
603-B COUNTRY CLUB DR.
BENSENVILLE,  IL  60106 -1329
Applicant Contact GEORGE NICOLAE
Correspondent
AMERICAN DENTAL PRODUCTS, INC.
603-B COUNTRY CLUB DR.
BENSENVILLE,  IL  60106 -1329
Correspondent Contact GEORGE NICOLAE
Regulation Number872.1740
Classification Product Code
LFC  
Date Received12/27/1999
Decision Date 03/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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