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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K954701
Device Name AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
Applicant
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157
Applicant Contact GEORGE NICOLAE
Correspondent
American Dental Products, Inc.
P.O. Box 435
Medinah,  IL  60157
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3765
Classification Product Code
EBC  
Date Received10/12/1995
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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