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FDA 510(k)

可灭菌托盘（Glidewell HT™ 种植导板手术套装，Glidewell HT™ 种植手术套装，Glidewell™ 假体套装）

K号: K242564 · 2025-03-21

申请人Prismatik Dentalcraft, Inc.
决定日期2025-03-21
产品代码KCT
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) 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 2025-03-21 under 510(k) number K242564. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)?

Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K242564.

When did Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) receive FDA 510(k) clearance?

Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) received FDA 510(k) clearance on 2025-03-21, under 510(k) number K242564.

Who is the listed applicant for Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)?

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 Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)?

The FDA product code for Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) is KCT.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 PLUSK252582与Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems兼容的Inclusive®钛连接件K252446BruxZir® NOWK250302柔性部分树脂

查看所有 37 个设备 →

相关器械（代码：KCT）

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。

K253988LiteSet托盘Nobel Biocare ABK261935外科和假肢托盘Dentsply Sirona, Inc.K253187SteriBest® 消毒托盘系统Mastel SurgicalK252854SteriTite 容器系统与 MediTray 产品Case Medical, Inc.K260726Straumann® ProClean™托盘（041.800；041.801）Institut Straumann AGK253791PUREVUE™ 快速连接导管系统托盘；PUREVUE™ 快速连接导管系统盖DePuy Mitek, Inc.

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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