FDA 510(k)

美登達CAD/CAM牙橋

K 號：K242542 · 2025-04-22

決定日期2025-04-22

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Medentika CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K242542. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medentika CAD/CAM Abutments?

Medentika CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Medentika GmbH. The 510(k) number is K242542.

When did Medentika CAD/CAM Abutments receive FDA 510(k) clearance?

Medentika CAD/CAM Abutments received FDA 510(k) clearance on 2025-04-22, under 510(k) number K242542.

Who is the listed applicant for Medentika CAD/CAM Abutments?

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

What is the FDA product code for Medentika CAD/CAM Abutments?

The FDA product code for Medentika CAD/CAM Abutments is NHA.

其他以 Medentika 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。

K253341自訂基座 AS K223113Medentika 牙槽系統，Medentika CAD/CAM 牙槽，Medentika CAD/CAM TiBases，Medentika 多單元牙槽 K201711CARES 螺釘 - 留置橋梁和橋梁 (SRBB)K200906MINICONE 偽裝體 K191123多單位牙根支台 K180564Medentika 牙槽系統，Medentika CAD/CAM 牙槽，Medentika CAD/CAM TiBases

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相關器械（代碼：NHA）

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。

K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLC K253999通用基座 ASC 接合；通用基座 ASC 非接合；通用基座 MUA ASC；臨時基座接合和非接合；恢復基座極锥連接；Omnigrip臨床螺釘鈦金；Omnigrip假牙螺釘Nobel Biocare AB K261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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