FDA 510(k)

Inspire ICE即Inspire ICE清晰托架

K号: K171844 · 2017-07-18

决定日期2017-07-18

产品代码NJM

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决定实质等同

器械摘要

Inspire ICE aka Inspire ICE Clear Brackets is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171844. 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 Inspire ICE aka Inspire ICE Clear Brackets?

Inspire ICE aka Inspire ICE Clear Brackets is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Ormco Corporation. The 510(k) number is K171844.

When did Inspire ICE aka Inspire ICE Clear Brackets receive FDA 510(k) clearance?

Inspire ICE aka Inspire ICE Clear Brackets received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171844.

Who is the listed applicant for Inspire ICE aka Inspire ICE Clear Brackets?

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

What is the FDA product code for Inspire ICE aka Inspire ICE Clear Brackets?

The FDA product code for Inspire ICE aka Inspire ICE Clear Brackets is NJM.

列明Ormco Corporation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。

K250487SparkTM Clear 正畸器系统 K250015Ormco® EtchFree Bonding System, Ormco® EtchFree Bonding Primer, Ormco® EtchFree Adhesive K240501Spark™ Clear 正畸器系统 K203737Spark Clear 正畸器系统 K172845Symetri Clear

官方来源

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