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510(k) K182833

ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer by The Argen Corporation — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2019
Date Received
October 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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