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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 K950512
Device Name AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
Applicant
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157
Applicant Contact GEORGE NICOAE
Correspondent
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157
Correspondent Contact GEORGE NICOAE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/06/1995
Decision Date 03/07/1995
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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