FDA 510(k)

JDEvolution Plus L和JDEvolution Plus LE

K号: K251148 · 2025-09-25

决定日期2025-09-25

产品代码DZE

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决定实质等同

器械摘要

JDEvolution Plus L and JDEvolution Plus LE is the device name listed in this FDA 510(k) record. The listed applicant is Jdentalcare Srl. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251148. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the JDEvolution Plus L and JDEvolution Plus LE?

JDEvolution Plus L and JDEvolution Plus LE is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Jdentalcare Srl. The 510(k) number is K251148.

When did JDEvolution Plus L and JDEvolution Plus LE receive FDA 510(k) clearance?

JDEvolution Plus L and JDEvolution Plus LE received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251148.

Who is the listed applicant for JDEvolution Plus L and JDEvolution Plus LE?

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

What is the FDA product code for JDEvolution Plus L and JDEvolution Plus LE?

The FDA product code for JDEvolution Plus L and JDEvolution Plus LE is DZE.

列明Jdentalcare 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。

K240143JDZygoma牙种植体 K233896JDentalCare牙种植体系统：JDEvolution；JDEvolution plus；JDIcon；JDIcon plus K182081JDentalCare种植体系统JDIcon

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。