FDA 510(k)

ICE 陶瓷，ICE 染料，Fresco

K号: K213722 · 2022-12-14

决定日期2022-12-14

产品代码EIH

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决定实质等同

器械摘要

ICE Ceramics, ICE Stains, Fresco is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn Srl. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K213722. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ICE Ceramics, ICE Stains, Fresco?

ICE Ceramics, ICE Stains, Fresco is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Zirkonzahn Srl. The 510(k) number is K213722.

When did ICE Ceramics, ICE Stains, Fresco receive FDA 510(k) clearance?

ICE Ceramics, ICE Stains, Fresco received FDA 510(k) clearance on 2022-12-14, under 510(k) number K213722.

Who is the listed applicant for ICE Ceramics, ICE Stains, Fresco?

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 ICE Ceramics, ICE Stains, Fresco?

The FDA product code for ICE Ceramics, ICE Stains, Fresco is EIH.

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 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 K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

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官方来源

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