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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 K891463
Device Name ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
Applicant
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Applicant Contact BRAHMA D SHARMA
Correspondent
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Correspondent Contact BRAHMA D SHARMA
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/15/1989
Decision Date 05/19/1989
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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