FDA 510(k)

Lucitone 数字打印牙托基托™ 系统

K号: K243336 · 2024-12-17

决定日期2024-12-17

产品代码EBI

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决定实质等同

器械摘要

Lucitone Digital Print Denture™ System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K243336. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lucitone Digital Print Denture™ System?

Lucitone Digital Print Denture™ System is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K243336.

When did Lucitone Digital Print Denture™ System receive FDA 510(k) clearance?

Lucitone Digital Print Denture™ System received FDA 510(k) clearance on 2024-12-17, under 510(k) number K243336.

Who is the listed applicant for Lucitone Digital Print Denture™ System?

FDA 510(k)记录中列出Dentsply Sirona, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Lucitone Digital Print Denture™ System?

The FDA product code for Lucitone Digital Print Denture™ System is EBI.

列明Dentsply Sirona, 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。

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官方来源

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