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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name activator, ultraviolet, for polymerization
510(k) Number K031615
Device Name SLED CURING LIGHT SYSTEM
Applicant
DENTSPLY INTERNATIONAL
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
DENTSPLY INTERNATIONAL
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received05/23/2003
Decision Date 07/21/2003
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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