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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 K031494
Device Name DOC'S BEST WHITE COPPER CEMENT
Applicant
Cooley & Cooley, Ltd.
12101-A Cullen Blvd.
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Cooley & Cooley, Ltd.
12101-A Cullen Blvd.
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number872.3275
Classification Product Code
EMA  
Date Received05/13/2003
Decision Date 11/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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