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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K951607
Device Name SUREFLEX FILES
Applicant
Dentsply Intl.
500 W. College Ave.
York,  PA  17404
Applicant Contact P. J LEHN
Correspondent
Dentsply Intl.
500 W. College Ave.
York,  PA  17404
Correspondent Contact P. J LEHN
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received03/16/1995
Decision Date 06/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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