FDA 510(k)

MIST IC

K号: K222368 · 2022-12-01

决定日期2022-12-01

产品代码NHA

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决定实质等同

器械摘要

MIST IC is the device name listed in this FDA 510(k) record. The listed applicant is Imagine Milling Technologies, LLC. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222368. 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 MIST IC?

MIST IC is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Imagine Milling Technologies, LLC. The 510(k) number is K222368.

When did MIST IC receive FDA 510(k) clearance?

MIST IC received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222368.

Who is the listed applicant for MIST IC?

The FDA 510(k) record lists Imagine Milling Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIST IC?

The FDA product code for MIST IC is NHA.

列明Imagine Milling Technologies, LLC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。

K261122MIST IC K243009MIST IC K182246MIST IC

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。

K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台启动和非启动；愈合基台锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝Nobel Biocare AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方来源

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