FDA 510(k)

Renamel® 微混合；Renamel® 流動微混合

K 號：K222435 · 2022-10-11

決定日期2022-10-11

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Renamel® Microhybrid ;Renamel® Flowable Microhybrid is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K222435. 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® Microhybrid ;Renamel® Flowable Microhybrid?

Renamel® Microhybrid ;Renamel® Flowable Microhybrid is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Cosmedent, Inc.. The 510(k) number is K222435.

When did Renamel® Microhybrid ;Renamel® Flowable Microhybrid receive FDA 510(k) clearance?

Renamel® Microhybrid ;Renamel® Flowable Microhybrid received FDA 510(k) clearance on 2022-10-11, under 510(k) number K222435.

Who is the listed applicant for Renamel® Microhybrid ;Renamel® Flowable Microhybrid?

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® Microhybrid ;Renamel® Flowable Microhybrid?

The FDA product code for Renamel® Microhybrid ;Renamel® Flowable Microhybrid 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。

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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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