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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K954374
Device Name AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
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 Number872.3750
Classification Product Code
DYH  
Date Received09/19/1995
Decision Date 10/19/1995
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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