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510(k) K173971

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent by Yeti Dentalprodukte GmbH — Product Code EIH

K173971 is an FDA 510(k) premarket notification submitted by Yeti Dentalprodukte GmbH for the device "K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent". The FDA issued a decision of Substantially Equivalent on Nov 15, 2018. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 15, 2018
Date Received
Dec 29, 2017
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
510(k)

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FDA data resources