FDA 510(k)

正畸陶瓷托槽 1.1

K 號：K160615 · 2016-08-26

決定日期2016-08-26

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Tomy, Inc. 為申請人之記錄

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相關器械（代碼：NJM）

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