FDA 510(k)

BruxZir® NOW SRC

K号: K231940 · 2024-05-15

决定日期2024-05-15

产品代码NHA

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决定实质等同

器械摘要

BruxZir® NOW SRC is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2024-05-15 under 510(k) number K231940. 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 BruxZir® NOW SRC?

BruxZir® NOW SRC is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K231940.

When did BruxZir® NOW SRC receive FDA 510(k) clearance?

BruxZir® NOW SRC received FDA 510(k) clearance on 2024-05-15, under 510(k) number K231940.

Who is the listed applicant for BruxZir® NOW SRC?

FDA 510(k)记录将Prismatik Dentalcraft, Inc.列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for BruxZir® NOW SRC?

The FDA product code for BruxZir® NOW SRC is NHA.

列明Prismatik Dentalcraft, 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。

K261802Glidewell™ 牙托树脂 K262239Obsidian® 压力压过氧化锆 K254283BruxZir® Shaded 16 PLUS K252582与Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems兼容的Inclusive®钛连接件 K252446BruxZir® NOW K250302柔性部分树脂

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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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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。