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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K940546
Device Name GRANITEC IONOMER RESIN CEMENT
Applicant
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Applicant Contact SHARON A LUTTON
Correspondent
Confi-Dental Products Co.
385 S. Pierce Ave.
Colorado Tech Center
Louisville,  CO  80027
Correspondent Contact SHARON A LUTTON
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/07/1994
Decision Date 04/29/1994
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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