FDA 510(k)

Spark Clear 正畸器系统

K号: K203737 · 2021-03-22

决定日期2021-03-22

产品代码NXC

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决定实质等同

器械摘要

Spark Clear Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2021-03-22 under 510(k) number K203737. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Spark Clear Aligner System?

Spark Clear Aligner System is a medical device that received FDA 510(k) clearance on 2021-03-22. The listed applicant is Ormco Corporation. The 510(k) number is K203737.

When did Spark Clear Aligner System receive FDA 510(k) clearance?

Spark Clear Aligner System received FDA 510(k) clearance on 2021-03-22, under 510(k) number K203737.

Who is the listed applicant for Spark Clear Aligner System?

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 Spark Clear Aligner System?

The FDA product code for Spark Clear Aligner System is NXC.

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 K172845Symetri Clear 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。