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FDA 510(k)

Panthera咬合矫正器

K号: K203596 · 2021-04-20

决定日期2021-04-20
产品代码MQC
决定实质等同

器械摘要

Panthera Occlusal Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Panthera Dental, Inc.. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K203596. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the Panthera Occlusal Appliance?

Panthera Occlusal Appliance is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Panthera Dental, Inc.. The 510(k) number is K203596.

When did Panthera Occlusal Appliance receive FDA 510(k) clearance?

Panthera Occlusal Appliance received FDA 510(k) clearance on 2021-04-20, under 510(k) number K203596.

Who is the listed applicant for Panthera Occlusal Appliance?

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

What is the FDA product code for Panthera Occlusal Appliance?

The FDA product code for Panthera Occlusal Appliance is MQC.

相关临床试验

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。

列明Panthera Dental, 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。

相关器械(代码:MQC)

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。

官方来源

在 FDA 数据库中查看 →

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。

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