FDA 510(k)

Symetri Clear

K号: K172845 · 2018-01-31

决定日期2018-01-31

产品代码NJM

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决定实质等同

器械摘要

Symetri Clear is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K172845. 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 Symetri Clear?

Symetri Clear is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Ormco Corporation. The 510(k) number is K172845.

When did Symetri Clear receive FDA 510(k) clearance?

Symetri Clear received FDA 510(k) clearance on 2018-01-31, under 510(k) number K172845.

Who is the listed applicant for Symetri Clear?

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 Symetri Clear?

The FDA product code for Symetri Clear 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 K171844Inspire ICE即Inspire ICE清晰托架

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。