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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K032851
Device Name ULTRACROWN 75 ALLOY
Applicant
Dentsply International
570 W. College Ave.
York,  PA  17405
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply International
570 W. College Ave.
York,  PA  17405
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3060
Classification Product Code
EJT  
Date Received09/12/2003
Decision Date 09/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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