FDA 510(k)

優質加強版 C01/C02 LED 紫外線固化燈

K 號：K153514 · 2016-08-22

決定日期2016-08-22

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

Premium Plus C01/C02 LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus International Limited. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K153514. 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 Premium Plus C01/C02 LED Curing Light?

Premium Plus C01/C02 LED Curing Light is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Premium Plus International Limited. The 510(k) number is K153514.

When did Premium Plus C01/C02 LED Curing Light receive FDA 510(k) clearance?

Premium Plus C01/C02 LED Curing Light received FDA 510(k) clearance on 2016-08-22, under 510(k) number K153514.

Who is the listed applicant for Premium Plus C01/C02 LED Curing Light?

The FDA 510(k) record lists Premium Plus International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premium Plus C01/C02 LED Curing Light?

The FDA product code for Premium Plus C01/C02 LED Curing Light is EBZ.

其他以 Premium Plus International Limited 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。

K170261優質加強型預防牙科空氣機器 K163447優級加值一次性防護袖套

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

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