歯列矯正装置（モデル：HK-Y-0.4、HK-Y-0.45、HK-Y-0.63、HK-Y-0.7、HK-Y-ST-0.76、HK-Y-CF-0.76、HK-Y-0.9、HK-Y-1.0、HK-Y-2.0）

Question 1

What is the Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)?

Answer

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.. The 510(k) number is K230237.

Question 2

When did Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) receive FDA 510(k) clearance?

Answer

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) received FDA 510(k) clearance on 2023-09-14, under 510(k) number K230237.

Question 3

Who is the listed applicant for Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)?

Answer

The FDA 510(k) record lists Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

Question 4

What is the FDA product code for Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)?

Answer

The FDA product code for Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) is MQC.

歯列矯正装置（モデル：HK-Y-0.4、HK-Y-0.45、HK-Y-0.63、HK-Y-0.7、HK-Y-ST-0.76、HK-Y-CF-0.76、HK-Y-0.9、HK-Y-1.0、HK-Y-2.0）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：MQC）

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