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FDA 510(k)

Non-Sterile Zirconia Block

K-Number: K201492 · 2021-03-10

ApplicantBioden Co., Ltd.
Decision Date2021-03-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Non-Sterile Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Bioden Co., Ltd.. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K201492. 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 Non-Sterile Zirconia Block?

Non-Sterile Zirconia Block is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Bioden Co., Ltd.. The 510(k) number is K201492.

When did Non-Sterile Zirconia Block receive FDA 510(k) clearance?

Non-Sterile Zirconia Block received FDA 510(k) clearance on 2021-03-10, under 510(k) number K201492.

Who is the listed applicant for Non-Sterile Zirconia Block?

The FDA 510(k) record lists Bioden Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Sterile Zirconia Block?

The FDA product code for Non-Sterile Zirconia Block is EIH.

Other records listing Bioden Co., Ltd. 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.

K190139Zircos-Com

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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