FDA 510(k)

預燒結氧化鋁著色液

K 號：K232682 · 2024-03-19

申請人Chengdu Besmile Medical Technology Co., Ltd.

決定日期2024-03-19

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Pre-Sintered Zirconia Coloring Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K232682. 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 Pre-Sintered Zirconia Coloring Liquid?

Pre-Sintered Zirconia Coloring Liquid is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K232682.

When did Pre-Sintered Zirconia Coloring Liquid receive FDA 510(k) clearance?

Pre-Sintered Zirconia Coloring Liquid received FDA 510(k) clearance on 2024-03-19, under 510(k) number K232682.

Who is the listed applicant for Pre-Sintered Zirconia Coloring Liquid?

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

What is the FDA product code for Pre-Sintered Zirconia Coloring Liquid?

The FDA product code for Pre-Sintered Zirconia Coloring Liquid is EIH.

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相關器械（代碼：EIH）

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