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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K041335
Device Name PTM SYSTEM
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 Number872.6660
Classification Product Code
EIH  
Date Received05/18/2004
Decision Date 06/16/2004
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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