FDA 510(k)

BracePaste MTP 光固化底漆

K 號：K181910 · 2018-10-15

決定日期2018-10-15

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

BracePaste MTP Light Cure Primer is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2018-10-15 under 510(k) number K181910. 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 BracePaste MTP Light Cure Primer?

BracePaste MTP Light Cure Primer is a medical device that received FDA 510(k) clearance on 2018-10-15. The listed applicant is American Orthodontics. The 510(k) number is K181910.

When did BracePaste MTP Light Cure Primer receive FDA 510(k) clearance?

BracePaste MTP Light Cure Primer received FDA 510(k) clearance on 2018-10-15, under 510(k) number K181910.

Who is the listed applicant for BracePaste MTP Light Cure Primer?

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

What is the FDA product code for BracePaste MTP Light Cure Primer?

The FDA product code for BracePaste MTP Light Cure Primer is KLE.

其他以 American Orthodontics 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。

K261840BracePaste Prime Plus K232011Cleo K202276BracePaste 腰帶及建構系統 K172953酸蝕劑 K160782BracePaste膠帶

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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