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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 K951425
Device Name SPECTRUM CURING LIGHT POLYMERIZATION UNIT
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact P. J LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact P. J LEHN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received03/27/1995
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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