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FDA 510(k)

KATANA Zirconia Block

K-Number: K170986 · 2017-07-13

Decision Date2017-07-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KATANA Zirconia Block is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2017-07-13 under approval number K170986. 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 KATANA Zirconia Block?

KATANA Zirconia Block is a medical device that received FDA 510(k) clearance on 2017-07-13. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K170986.

When was KATANA Zirconia Block approved by the FDA?

KATANA Zirconia Block received FDA 510(k) clearance on 2017-07-13, under approval number K170986.

What company makes KATANA Zirconia Block?

KATANA Zirconia Block is manufactured by Kuraray Noritake Dental, Inc..

What is the FDA product code for KATANA Zirconia Block?

The FDA product code for KATANA Zirconia Block is EIH.

Other Devices by Kuraray Noritake Dental, Inc.

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Official Source

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