FDA 510(k)

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K 號：K191123 · 2020-01-06

決定日期2020-01-06

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Multi-unit 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 2020-01-06 under 510(k) number K191123. 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 Multi-unit Abutments?

Multi-unit Abutments is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Medentika GmbH. The 510(k) number is K191123.

When did Multi-unit Abutments receive FDA 510(k) clearance?

Multi-unit Abutments received FDA 510(k) clearance on 2020-01-06, under 510(k) number K191123.

Who is the listed applicant for Multi-unit 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 Multi-unit Abutments?

The FDA product code for Multi-unit 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 K242542美登達CAD/CAM牙橋 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 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。

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官方來源

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