FDA 510(k)

治療光，型號：MaxCure 9

K 號：K223414 · 2023-11-15

申請人Guilin Refine Medical Instrument Co., Ltd.

決定日期2023-11-15

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

Curing Light, Model: MaxCure 9 is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-11-15 under 510(k) number K223414. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Curing Light, Model: MaxCure 9?

Curing Light, Model: MaxCure 9 is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K223414.

When did Curing Light, Model: MaxCure 9 receive FDA 510(k) clearance?

Curing Light, Model: MaxCure 9 received FDA 510(k) clearance on 2023-11-15, under 510(k) number K223414.

Who is the listed applicant for Curing Light, Model: MaxCure 9?

The FDA 510(k) record lists Guilin Refine Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Curing Light, Model: MaxCure 9?

The FDA product code for Curing Light, Model: MaxCure 9 is EBZ.

其他以 Guilin Refine Medical Instrument Co., Ltd. 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。

K254018攜帶式牙科X光設備（GT-1）K230641超聲波刮治器針頭

相關器械（代碼：EBZ）

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。

K253131治療光源（M-Cure 6）Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461德米專業版Meta Systems Co., Ltd.K242386藍月Genoss Co., Ltd.K243921LED固化燈（DB686 HALO）Foshan Coxo Medical Instrument Co., Ltd.K250009LED固化燈（C01-X，C02-X）Premium Plus (Dongguan) Limited K241238LOOP™ LED 紫外線固化燈系統 (CLK01)Garrison Dental Solutions, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。