FDA 510(k)

BracePaste MTP光固化底漆

K号: K181910 · 2018-10-15

决定日期2018-10-15

产品代码KLE

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决定实质等同

器械摘要

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.

常见问题

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.

列明American Orthodontics为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261840BracePaste Prime Plus K232011Cleo K202276BracePaste Band and Build LC K172953酸蚀剂 K160782BracePaste粘合剂

官方来源

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