FDA 510(k)

Implantmed Plus II & Piezomed Plus II 模块

K号: K253776 · 2026-06-18

决定日期2026-06-18

产品代码DZI

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决定实质等同

器械摘要

Implantmed Plus II & Piezomed Plus II Module is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253776. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Implantmed Plus II & Piezomed Plus II Module?

Implantmed Plus II & Piezomed Plus II Module is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K253776.

When did Implantmed Plus II & Piezomed Plus II Module receive FDA 510(k) clearance?

Implantmed Plus II & Piezomed Plus II Module received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253776.

Who is the listed applicant for Implantmed Plus II & Piezomed Plus II Module?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implantmed Plus II & Piezomed Plus II Module?

The FDA product code for Implantmed Plus II & Piezomed Plus II Module is DZI.

列明W&H Dentalwerk Buermoos GmbH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。

K243280Piezomed Pro（Piezomed Pro 模块 M-PM100 包括手柄 M-PH350，Piezomed Pro 工具（各种尖端）和附件）K201703PROXEO Twist 无线抛光系统 PL-40 H K181858电动手持电机 K171553W&H Assistina 双胞胎

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