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FDA 510(k)

Glass Ceramic

K-Number: K252789 · 2025-12-08

ApplicantShenzhen Xiangtong Co., Ltd.
Decision Date2025-12-08
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Glass Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xiangtong Co., Ltd.. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K252789. 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 Glass Ceramic?

Glass Ceramic is a medical device that received FDA 510(k) clearance on 2025-12-08. The listed applicant is Shenzhen Xiangtong Co., Ltd.. The 510(k) number is K252789.

When did Glass Ceramic receive FDA 510(k) clearance?

Glass Ceramic received FDA 510(k) clearance on 2025-12-08, under 510(k) number K252789.

Who is the listed applicant for Glass Ceramic?

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

What is the FDA product code for Glass Ceramic?

The FDA product code for Glass 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.

NCT06898411Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth RestorationsCOMPLETEDNCT07521501Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal DesignNOT_YET_RECRUITING

Other records listing Shenzhen Xiangtong 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.

K223192XT Stain/GlazeK223194Glass Ceramic

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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