FDA 510(k)

Ambar, Ambar APS, Ambar Universal APS

K 號：K183424 · 2019-12-13

決定日期2019-12-13

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

Ambar, Ambar APS, Ambar Universal APS is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K183424. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ambar, Ambar APS, Ambar Universal APS?

Ambar, Ambar APS, Ambar Universal APS is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Dentscare Ltda. The 510(k) number is K183424.

When did Ambar, Ambar APS, Ambar Universal APS receive FDA 510(k) clearance?

Ambar, Ambar APS, Ambar Universal APS received FDA 510(k) clearance on 2019-12-13, under 510(k) number K183424.

Who is the listed applicant for Ambar, Ambar APS, Ambar Universal APS?

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

What is the FDA product code for Ambar, Ambar APS, Ambar Universal APS?

The FDA product code for Ambar, Ambar APS, Ambar Universal APS is KLE.

其他以 Dentscare Ltda 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。

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相關器械（代碼：KLE）

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。

K262252MPa 最大膠粘劑Den-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products Company K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

官方來源

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