FDA 510(k)

Prima Plus锥形植入系统

K号: K240966 · 2024-07-09

决定日期2024-07-09

产品代码DZE

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决定实质等同

器械摘要

Prima Plus Conical Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Dental, Inc.. It received FDA 510(k) clearance on 2024-07-09 under 510(k) number K240966. 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 Prima Plus Conical Implant System?

Prima Plus Conical Implant System is a medical device that received FDA 510(k) clearance on 2024-07-09. The listed applicant is Keystone Dental, Inc.. The 510(k) number is K240966.

When did Prima Plus Conical Implant System receive FDA 510(k) clearance?

Prima Plus Conical Implant System received FDA 510(k) clearance on 2024-07-09, under 510(k) number K240966.

Who is the listed applicant for Prima Plus Conical Implant System?

The FDA 510(k) record lists Keystone Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prima Plus Conical Implant System?

The FDA product code for Prima Plus Conical Implant System is DZE.

列明Keystone Dental, 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。

K223814Genesis ACTIVE植入系统 K221381KDG基台 K201334Keystone Dental XL 牙种植系统

官方来源

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