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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K954133
Device Name AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
Applicant
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157 -0435
Applicant Contact GEORGE NICOLAE
Correspondent
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157 -0435
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/01/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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