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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K955328
Device Name CONFI-BOND
Applicant
Confi-Dental Products Co.
416 S. Taylor Ave.
Louisville,  CO  80027 -3028
Applicant Contact SHARON A LUTTON
Correspondent
Confi-Dental Products Co.
416 S. Taylor Ave.
Louisville,  CO  80027 -3028
Correspondent Contact SHARON A LUTTON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/20/1995
Decision Date 03/28/1996
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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