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510(k) K190627

VALO Grand Corded by Ultradent Products, Inc. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2019
Date Received
March 12, 2019
Clearance Type
Special
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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