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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K040144
Device Name QUIXX POSTERIOR RESTORATIVE
Applicant
DENTSPLY INTERNATIONAL
221 WEST PHILADELPHIA ST.
SUITE 60
YORK,  PA  17404
Applicant Contact P JEFFERY LEHN
Correspondent
DENTSPLY INTERNATIONAL
221 WEST PHILADELPHIA ST.
SUITE 60
YORK,  PA  17404
Correspondent Contact P JEFFERY LEHN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/22/2004
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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