FDA 510(k)

FX對抗

K 號：K222518 · 2022-11-17

決定日期2022-11-17

產品代碼EGS

諮詢委員會DE

決定相當於

器材摘要

FX Contra is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K222518. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FX Contra?

FX Contra is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Nakanishi, Inc.. The 510(k) number is K222518.

When did FX Contra receive FDA 510(k) clearance?

FX Contra received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222518.

Who is the listed applicant for FX Contra?

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

What is the FDA product code for FX Contra?

The FDA product code for FX Contra is EGS.

其他以 Nakanishi, 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：EGS）

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。

K251869一次性預防角（3399-60，3399-090，3399-105）Premium Plus (Dongguan) Limited K240950一次性預防角Pacific Care Limited K240183星 E900 手柄系列Dentalez, Inc., Stardental Division K230106一般切割直刀Nakanishi, Inc.K220346蓮花牙科角Ajk Engineering, Inc.K220874平滑駕動對角和直角手柄Lares Research

官方來源

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