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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dental barriers and sleeves
510(k) Number K160232
Device Name Disposable Barrier Sleeves and Covers
Applicant
DENTSPLY International Inc.
221 West Philadephia Street, Suite 60
York,  PA  17408
Applicant Contact Helen Lewis
Correspondent
DENTSPLY International Inc.
221 West Philadephia Street, Suite 60
York,  PA  17408
Correspondent Contact Helen Lewis
Regulation Number878.4370
Classification Product Code
PEM  
Date Received02/01/2016
Decision Date 06/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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