FDA 510(k)

牙科氧化锆空白 & 牙科氧化锆预着色空白

K号: K221051 · 2022-07-08

申请人Changsha Honchon Technology Co., Ltd.

决定日期2022-07-08

产品代码EIH

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决定实质等同

器械摘要

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Honchon Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K221051. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Changsha Honchon Technology Co., Ltd.. The 510(k) number is K221051.

When did Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2022-07-08, under 510(k) number K221051.

Who is the listed applicant for Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

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

What is the FDA product code for Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

官方来源

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牙科氧化锆空白 & 牙科氧化锆预着色空白

器械摘要

常见问题

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