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FDA 510(k)

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

K-Number: K180252 · 2018-04-24

ApplicantCrown Porcelain Dental Technology Co., Ltd.
Decision Date2018-04-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Crown Porcelain Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K180252. 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 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Crown Porcelain Dental Technology Co., Ltd.. The 510(k) number is K180252.

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

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2018-04-24, under 510(k) number K180252.

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

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

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

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

Related Clinical Trials

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.

NCT03917927A Clinical Study of the Eztetic Dental Implant SystemCOMPLETEDNCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITINGNCT07672470Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary MolarsACTIVE_NOT_RECRUITING

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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