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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 K901697
Device Name SILISTOR CERAMIC AND RESIN REPAIR SYSTEM
Applicant
Kulzer, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Applicant Contact AN-SHIH CHENG
Correspondent
Kulzer, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/10/1990
Decision Date 06/15/1990
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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