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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, prescription
510(k) Number K072522
Device Name THERMOFORM SHEET MATERIALS AND ACCESSORIES
Applicant
DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST.
SUITE 60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST.
SUITE 60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Classification Product Code
MQC  
Date Received09/07/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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