FDA 510(k)

植入式醫療設備 Plus II 及 Piezomed Plus II 模組

K 號：K253776 · 2026-06-18

決定日期2026-06-18

產品代碼DZI

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 W&H Dentalwerk Buermoos GmbH 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243280Piezomed Pro (Piezomed Pro 模組 M-PM100 擴含手柄 M-PH350，Piezomed Pro 器材（各種尖端）及附件）K201703PROXEO Twist 電動磨光系統 PL-40 H K181858電動手持式機械頭電機 K171553W&H 協助儀雙用

相關器械（代碼：DZI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253655斜角螺絲刀醫療設備 (M-SD090)W&H Dentalwerk Bürmoos GmbH K254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340外科驅動系統（型號：ES70、ES90、E8）Guangdong Jinme Medical Technology Co., Ltd.K231087導航手術套件Implant Direct Sybron Manufacturing, LLC K192561特拉烏斯 SUS20Saeshin Precision Co., Ltd.

官方來源

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