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FDA 510(k)

XT Stain/Glaze

K-Number: K223192 · 2023-03-27

ApplicantShenzhen Xiangtong Co., Ltd.
Decision Date2023-03-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XT Stain/Glaze 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 2023-03-27 under 510(k) number K223192. 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 XT Stain/Glaze?

XT Stain/Glaze is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Shenzhen Xiangtong Co., Ltd.. The 510(k) number is K223192.

When did XT Stain/Glaze receive FDA 510(k) clearance?

XT Stain/Glaze received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223192.

Who is the listed applicant for XT Stain/Glaze?

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 XT Stain/Glaze?

The FDA product code for XT Stain/Glaze is EIH.

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.

K252789Glass CeramicK223194Glass 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

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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