FDA 510(k)

XT 染色/釉面

K 號：K223192 · 2023-03-27

決定日期2023-03-27

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shenzhen Xiangtong Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252789玻璃陶瓷 K223194玻璃陶瓷

相關器械（代碼：EIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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