FDA 510(k)

Concentrix MX-AC 高速手持式工具

K 號：K173465 · 2018-03-28

決定日期2018-03-28

產品代碼EFB

諮詢委員會DE

決定相當於

器材摘要

Concentrix MX-AC High-Speed Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc.. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K173465. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Concentrix MX-AC High-Speed Handpiece?

Concentrix MX-AC High-Speed Handpiece is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Dentalez, Inc.. The 510(k) number is K173465.

When did Concentrix MX-AC High-Speed Handpiece receive FDA 510(k) clearance?

Concentrix MX-AC High-Speed Handpiece received FDA 510(k) clearance on 2018-03-28, under 510(k) number K173465.

Who is the listed applicant for Concentrix MX-AC High-Speed Handpiece?

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

What is the FDA product code for Concentrix MX-AC High-Speed Handpiece?

The FDA product code for Concentrix MX-AC High-Speed Handpiece is EFB.

其他以 Dentalez, Inc. 為申請人之記錄

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相關器械（代碼：EFB）

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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