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510(k) K190272

Bluephase PowerCure by Ivoclar Vivadent, AG — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2019
Date Received
February 8, 2019
Clearance Type
Traditional
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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