FDA 510(k)

Bloomden牙科氧化锆空白牙 & 牙科氧化锆预着色空白

K号: K260370 · 2026-03-30

申请人Bloomden Bioceramics (HuNan) Co., Ltd.

决定日期2026-03-30

产品代码EIH

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决定实质等同

器械摘要

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Bloomden Bioceramics (HuNan) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K260370. 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 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Bloomden Bioceramics (HuNan) Co., Ltd.. The 510(k) number is K260370.

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

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2026-03-30, under 510(k) number K260370.

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

The FDA 510(k) record lists Bloomden Bioceramics (HuNan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

列明Bloomden Bioceramics (HuNan) Co., Ltd.为申报人的其他记录

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K212765Bloomden牙科氧化锆空白牙 & 牙科氧化锆预着色空白

官方来源

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