FDA 510(k)

NobelZygoma PureSet™ 盘

K号: K231219 · 2023-06-27

决定日期2023-06-27

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

NobelZygoma PureSet™ Tray is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K231219. 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 NobelZygoma PureSet™ Tray?

NobelZygoma PureSet™ Tray is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K231219.

When did NobelZygoma PureSet™ Tray receive FDA 510(k) clearance?

NobelZygoma PureSet™ Tray received FDA 510(k) clearance on 2023-06-27, under 510(k) number K231219.

Who is the listed applicant for NobelZygoma PureSet™ Tray?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NobelZygoma PureSet™ Tray?

The FDA product code for NobelZygoma PureSet™ Tray is KCT.

列明Nobel Biocare Services AG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。

K220339Esthetic Abutments Nobel Biocare N1 K220048NobelProcera 氧化锆 N1 底座 K211109N1 TiUltra TCC 植入系统 K212932Nobel Biocare NobelSpeedy Groovy / Branemark 系统Mk III TiUnite / Replace Select TC PureSet 盘

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。