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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 K954244
Device Name AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE
Applicant
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157
Applicant Contact GEORGE NICOALE
Correspondent
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157
Correspondent Contact GEORGE NICOALE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received09/11/1995
Decision Date 10/12/1995
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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