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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 K190272
Device Name Bluephase PowerCure
Applicant
Ivoclar Vivadent, AG
Bendererstrasse 2
Schaan,  LI FL-9494
Applicant Contact Sandra Cakebread
Correspondent
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact Lori Aleshin
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received02/08/2019
Decision Date 07/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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