FDA 510(k)

Renamel NANO +plus

K 號：K163480 · 2017-02-24

決定日期2017-02-24

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Renamel NANO +plus is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K163480. 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 NANO +plus?

Renamel NANO +plus is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Cosmedent, Inc.. The 510(k) number is K163480.

When did Renamel NANO +plus receive FDA 510(k) clearance?

Renamel NANO +plus received FDA 510(k) clearance on 2017-02-24, under 510(k) number K163480.

Who is the listed applicant for Renamel NANO +plus?

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 NANO +plus?

The FDA product code for Renamel NANO +plus is EBF.

其他以 Cosmedent, Inc. 為申請人之記錄

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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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