FDA 510(k)

藍光相位 Style 20i

K 號：K163613 · 2017-04-04

決定日期2017-04-04

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

Bluephase Style 20i is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K163613. 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 Bluephase Style 20i?

Bluephase Style 20i is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K163613.

When did Bluephase Style 20i receive FDA 510(k) clearance?

Bluephase Style 20i received FDA 510(k) clearance on 2017-04-04, under 510(k) number K163613.

Who is the listed applicant for Bluephase Style 20i?

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

What is the FDA product code for Bluephase Style 20i?

The FDA product code for Bluephase Style 20i is EBZ.

其他以 Ivoclar Vivadent, AG 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。

K210804Adhese Universal DC, Cention Primer K211916IPS e.max One K193193Telio CAD牙橋解決方案- 過去系統 K191453Cervitec F K191448防護套管 K191382IPS e.max CAD 牙槽體解決方案 - 預設系統

查看所有 13 項裝置 →

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。