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510(k) K163613

Bluephase Style 20i by Ivoclar Vivadent, AG — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2017
Date Received
December 22, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

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