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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 K981813
Device Name PERMACEM AUTOMIX LUTING CEMENT SYSTEM
Applicant
Foremost Dental Mfg., Inc.
415 W. Aldine Ave. 10-A
Chicago,  IL  60657
Applicant Contact AN-SHIH CHENG
Correspondent
Foremost Dental Mfg., Inc.
415 W. Aldine Ave. 10-A
Chicago,  IL  60657
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/22/1998
Decision Date 07/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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