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FDA 510(k)

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent

K-Number: K173971 · 2018-11-15

ApplicantYeti Dentalprodukte GmbH
Decision Date2018-11-15
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is a medical device manufactured by Yeti Dentalprodukte GmbH. It received FDA 510(k) clearance on 2018-11-15 under approval number K173971. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent?

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is a medical device that received FDA 510(k) clearance on 2018-11-15. It is manufactured by Yeti Dentalprodukte GmbH. The 510(k) number is K173971.

When was K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent approved by the FDA?

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent received FDA 510(k) clearance on 2018-11-15, under approval number K173971.

What company makes K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent?

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is manufactured by Yeti Dentalprodukte GmbH.

What is the FDA product code for K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent?

The FDA product code for K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is EIH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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