FDA 510(k)

Renamel 大量填充器材

K 號：K211259 · 2021-06-24

決定日期2021-06-24

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Renamel Bulkfill is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K211259. 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 Renamel Bulkfill?

Renamel Bulkfill is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Cosmedent, Inc.. The 510(k) number is K211259.

When did Renamel Bulkfill receive FDA 510(k) clearance?

Renamel Bulkfill received FDA 510(k) clearance on 2021-06-24, under 510(k) number K211259.

Who is the listed applicant for Renamel Bulkfill?

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

What is the FDA product code for Renamel Bulkfill?

The FDA product code for Renamel Bulkfill is EBF.

其他以 Cosmedent, Inc. 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。

K240714保證®通用型；保證®通用型自動混和型 K222435Renamel® 微混合；Renamel® 流動微混合 K172707瑞奈美微填充 K163480Renamel NANO +plus

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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