FDA 510(k)

NextDent 牙齒假牙 3D+

K 號：K191497 · 2019-11-01

決定日期2019-11-01

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

NextDent Denture 3D+ is the device name listed in this FDA 510(k) record. The listed applicant is Vertex-Dental B.V.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K191497. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NextDent Denture 3D+?

NextDent Denture 3D+ is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K191497.

When did NextDent Denture 3D+ receive FDA 510(k) clearance?

NextDent Denture 3D+ received FDA 510(k) clearance on 2019-11-01, under 510(k) number K191497.

Who is the listed applicant for NextDent Denture 3D+?

The FDA 510(k) record lists Vertex-Dental B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextDent Denture 3D+?

The FDA product code for NextDent Denture 3D+ is EBI.

其他以 Vertex-Dental B.V. 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。

K241071NextDent Jet 牙托基座；NextDent Jet 牙托牙 K231388NextDent 基礎版 K221022NextDent 輔助正畸設備 K162572NextDent 牙齒假牙，E-牙齒假牙

相關器械（代碼：EBI）

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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