FDA 510(k)

MIS LOCKiT 基台系统，OT-等距器和球附件

K号: K182228 · 2019-01-28

决定日期2019-01-28

产品代码NHA

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决定实质等同

器械摘要

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182228. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K182228.

When did MIS LOCKiT Abutments System, OT-Equators and Ball Attachments receive FDA 510(k) clearance?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182228.

Who is the listed applicant for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is NHA.

列明Mis Implants Technologies , Ltd.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。

K180282MIS 内六角牙齿植入系统 K173326MIS CONNECT 锥形连接基台 K172505MIS C1 窄平台锥形连接植入系统，MIS C1 宽平台锥形连接基台 K163349MIS V3 锥形连接牙齿植入系统

相关器械（代码：NHA）

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。

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官方来源

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