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FDA 510(k)

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

K-Number: K230003 · 2023-03-31

ApplicantTopzir Biotech Co., Ltd.
Decision Date2023-03-31
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Topzir Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230003. 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 Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Topzir Biotech Co., Ltd.. The 510(k) number is K230003.

When did Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230003.

Who is the listed applicant for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

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

What is the FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

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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