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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 K042199
Device Name TRANSLUX POWER BLUE
Applicant
Heraeus Kulzer,GmbH
4315 S. Lafayette Blvd.
South Bend,  IN  46614 -2517
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer,GmbH
4315 S. Lafayette Blvd.
South Bend,  IN  46614 -2517
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/13/2004
Decision Date 09/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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