FDA 510(k)

正畸陶瓷托槽 1.1

K号: K160615 · 2016-08-26

决定日期2016-08-26

产品代码NJM

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决定实质等同

器械摘要

ORTHODONTIC CERAMIC BRACKETS 1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Tomy, Inc.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160615. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ORTHODONTIC CERAMIC BRACKETS 1.1?

ORTHODONTIC CERAMIC BRACKETS 1.1 is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Tomy, Inc.. The 510(k) number is K160615.

When did ORTHODONTIC CERAMIC BRACKETS 1.1 receive FDA 510(k) clearance?

ORTHODONTIC CERAMIC BRACKETS 1.1 received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160615.

Who is the listed applicant for ORTHODONTIC CERAMIC BRACKETS 1.1?

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

What is the FDA product code for ORTHODONTIC CERAMIC BRACKETS 1.1?

The FDA product code for ORTHODONTIC CERAMIC BRACKETS 1.1 is NJM.

列明Tomy, Inc.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。

K180718正畸塑料托槽和附件

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