FDA 510(k)

Paltop 窄植入

K号: K210117 · 2021-11-30

申请人Paltop Advanced Dental Solutions, Ltd.

决定日期2021-11-30

产品代码DZE

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决定实质等同

器械摘要

Paltop Narrow Implant is the device name listed in this FDA 510(k) record. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2021-11-30 under 510(k) number K210117. 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 Paltop Narrow Implant?

Paltop Narrow Implant is a medical device that received FDA 510(k) clearance on 2021-11-30. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K210117.

When did Paltop Narrow Implant receive FDA 510(k) clearance?

Paltop Narrow Implant received FDA 510(k) clearance on 2021-11-30, under 510(k) number K210117.

Who is the listed applicant for Paltop Narrow Implant?

The FDA 510(k) record lists Paltop Advanced Dental Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paltop Narrow Implant?

The FDA product code for Paltop Narrow Implant is DZE.

列明Paltop Advanced Dental Solutions, Ltd.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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