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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 K040906
Device Name CALIBRA CEMENT
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17404
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17404
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/07/2004
Decision Date 06/16/2004
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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