FDA 510(k)

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

K号: K181484 · 2018-06-18

决定日期2018-06-18

产品代码EBF

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决定实质等同

器械摘要

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn Srl. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K181484. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue?

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Zirkonzahn Srl. The 510(k) number is K181484.

When did Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue receive FDA 510(k) clearance?

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue received FDA 510(k) clearance on 2018-06-18, under 510(k) number K181484.

Who is the listed applicant for Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue?

The FDA 510(k) record lists Zirkonzahn Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue?

The FDA product code for Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue is EBF.

列明Zirkonzahn Srl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。

K232691Polibond K213722ICE 陶瓷，ICE 染料，Fresco K203765ZIRKONZAHN.植入计划器，ZIRKONZAHN.植入计划器实践，CAD/CAM STL转换器，CAD/CAM Z-Tray K200676ABRO 1，RESITON GINGIVA，PRIME 和 THERAPON TRANSPA K190518Color Liquid, Vita Liquid K183304Prettau, ICE, Z-White氧化锆空白

查看所有 7 个设备 →

官方来源

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