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FDA 510(k)

Dental Zirconia Ceramic

K-Number: K250811 · 2025-04-11

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2025-04-11
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Zirconia Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250811. 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 Dental Zirconia Ceramic?

Dental Zirconia Ceramic is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250811.

When did Dental Zirconia Ceramic receive FDA 510(k) clearance?

Dental Zirconia Ceramic received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250811.

Who is the listed applicant for Dental Zirconia Ceramic?

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

What is the FDA product code for Dental Zirconia Ceramic?

The FDA product code for Dental Zirconia Ceramic 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.

NCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITING

Other records listing Aidite (Qinhuangdao) Technology 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.

K253036Light-curing Coloring Materials (ALCM)K251415Additively Manufactured Aligner ResinK250534Biomic Color OpaqueK250497Additive Manufacturing (Light Curing) Crown Bridge ResinK250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )K242884Additively Manufactured Denture Resin

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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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