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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 K964133
Device Name AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
Applicant
American Dental Products, Inc.
22 W 246 Sunnyside Rd.
Medinah,  IL  60157 -9705
Applicant Contact GEORGE NICOLAE
Correspondent
American Dental Products, Inc.
22 W 246 Sunnyside Rd.
Medinah,  IL  60157 -9705
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/15/1996
Decision Date 01/09/1997
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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