FDA 510(k)

FUSION Plus 紫外線固化燈

K 號：K180065 · 2019-04-19

決定日期2019-04-19

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

FUSION Plus Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Dentlight, Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K180065. 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 FUSION Plus Curing Light?

FUSION Plus Curing Light is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Dentlight, Inc.. The 510(k) number is K180065.

When did FUSION Plus Curing Light receive FDA 510(k) clearance?

FUSION Plus Curing Light received FDA 510(k) clearance on 2019-04-19, under 510(k) number K180065.

Who is the listed applicant for FUSION Plus Curing Light?

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

What is the FDA product code for FUSION Plus Curing Light?

The FDA product code for FUSION Plus Curing Light is EBZ.

其他以 Dentlight, 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。

K201387超快速、超快速加強版、超快速輕量版

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。