FDA 510(k)

Infinix大範圍複合材，Infinix流動複合材，Infinix大量填充流動複合材

K 號：K201010 · 2020-08-14

決定日期2020-08-14

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is the device name listed in this FDA 510(k) record. The listed applicant is Nobio , Ltd.. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K201010. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Nobio , Ltd.. The 510(k) number is K201010.

When did Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite receive FDA 510(k) clearance?

Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite received FDA 510(k) clearance on 2020-08-14, under 510(k) number K201010.

Who is the listed applicant for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

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

What is the FDA product code for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite?

The FDA product code for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite is EBF.

其他以 Nobio , 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。

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相關器械（代碼：EBF）

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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官方來源

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