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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K061264
Device Name TEMPFX ESTHETIC PROVISIONAL SYSTEM
Applicant
Dentsply International, Inc.
221 W. Philadelphia St., SE 60
Susquehanna Commerce Ctr.
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International, Inc.
221 W. Philadelphia St., SE 60
Susquehanna Commerce Ctr.
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3770
Classification Product Code
EBG  
Date Received05/05/2006
Decision Date 05/23/2006
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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