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FDA 510(k)

Dental porcelain powder

K-Number: K242400 · 2024-10-10

ApplicantYilink (Tianjin) Biotechnology Co., Ltd.
Decision Date2024-10-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental porcelain powder is the device name listed in this FDA 510(k) record. The listed applicant is Yilink (Tianjin) Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K242400. 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 porcelain powder?

Dental porcelain powder is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Yilink (Tianjin) Biotechnology Co., Ltd.. The 510(k) number is K242400.

When did Dental porcelain powder receive FDA 510(k) clearance?

Dental porcelain powder received FDA 510(k) clearance on 2024-10-10, under 510(k) number K242400.

Who is the listed applicant for Dental porcelain powder?

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

What is the FDA product code for Dental porcelain powder?

The FDA product code for Dental porcelain powder is EIH.

Other records listing Yilink (Tianjin) Biotechnology 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.

K222513Glass CeramicsK222520Zirconia Block

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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