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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 K033520
Device Name BLUEPHASE
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 Received11/07/2003
Decision Date 12/05/2003
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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