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FDA 510(k)

Bloomden 牙科氧化鋯坯塊及牙科氧化鋯預染色坯塊

K 號：K212765 · 2021-11-15

申請人Bloomden Bioceramics (HuNan) Co., Ltd.
決定日期2021-11-15
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

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 2021-11-15 under 510(k) number K212765. 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 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 2021-11-15. The listed applicant is Bloomden Bioceramics (HuNan) Co., Ltd.. The 510(k) number is K212765.

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 2021-11-15, under 510(k) number K212765.

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.

相關臨床試驗

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。

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其他以 Bloomden Bioceramics (HuNan) 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。

K260370Bloomden 牙科氧化鋯坯塊及牙科氧化鋯預染色坯塊

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。

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