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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 K163613
Device Name Bluephase Style 20i
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 DONNA MARIE HARTNETT
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received12/22/2016
Decision Date 04/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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