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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 K110756
Device Name BLUEPHASE STYLE
Applicant
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact DONNA MARIE HARTNETT
Correspondent
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received03/18/2011
Decision Date 08/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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