FDA 510(k)

玻璃離子FX超級

K 號：K222253 · 2022-09-22

決定日期2022-09-22

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

GlasIonomer FX ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2022-09-22 under 510(k) number K222253. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GlasIonomer FX ULTRA?

GlasIonomer FX ULTRA is a medical device that received FDA 510(k) clearance on 2022-09-22. The listed applicant is Shofu Dental Corporation. The 510(k) number is K222253.

When did GlasIonomer FX ULTRA receive FDA 510(k) clearance?

GlasIonomer FX ULTRA received FDA 510(k) clearance on 2022-09-22, under 510(k) number K222253.

Who is the listed applicant for GlasIonomer FX ULTRA?

The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlasIonomer FX ULTRA?

The FDA product code for GlasIonomer FX ULTRA is EMA.

其他以 Shofu Dental Corporation 為申請人之記錄

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相關器械（代碼：EMA）

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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