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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K971603
Device Name STERILE SUREFLEX FILES AND INSTRUMENTS
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.4200
Classification Product Code
EFA  
Date Received05/01/1997
Decision Date 06/04/1997
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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