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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K850965
Device Name KULZER DENTIN ADHESIVE
Applicant
Kulzer, Inc.
111 N. Wabash Ave.
Chicago,  IL  60602
Applicant Contact ROBERT W BAUER
Correspondent
Kulzer, Inc.
111 N. Wabash Ave.
Chicago,  IL  60602
Correspondent Contact ROBERT W BAUER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/08/1985
Decision Date 04/22/1985
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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