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FDA 510(k)

KATANA Zirconia Block

K-Number: K170986 · 2017-07-13

ApplicantKuraray Noritake Dental, Inc.
Decision Date2017-07-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KATANA Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2017-07-13 under 510(k) 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. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K170986.

When did KATANA Zirconia Block receive FDA 510(k) clearance?

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

Who is the listed applicant for KATANA Zirconia Block?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KATANA Zirconia Block?

The FDA product code for KATANA Zirconia Block is EIH.

Other records listing Kuraray Noritake Dental, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250673CERABIEN MiLaiK233285KATANA Zirconia ONE For IMPLANTK231039CLEARFIL Universal Bond Quick 2K220369Esthetic ColorantK213147CERABIEN MiLaiK210504PANAVIA Veneer LC

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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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