FDA 510(k)

NextDent Jet 牙托基座；NextDent Jet 牙托牙

K 號：K241071 · 2024-09-04

決定日期2024-09-04

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

NextDent Jet Denture Base; NextDent Jet Denture Teeth 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 2024-09-04 under 510(k) number K241071. 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 Jet Denture Base; NextDent Jet Denture Teeth?

NextDent Jet Denture Base; NextDent Jet Denture Teeth is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K241071.

When did NextDent Jet Denture Base; NextDent Jet Denture Teeth receive FDA 510(k) clearance?

NextDent Jet Denture Base; NextDent Jet Denture Teeth received FDA 510(k) clearance on 2024-09-04, under 510(k) number K241071.

Who is the listed applicant for NextDent Jet Denture Base; NextDent Jet Denture Teeth?

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 Jet Denture Base; NextDent Jet Denture Teeth?

The FDA product code for NextDent Jet Denture Base; NextDent Jet Denture Teeth 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。

K231388NextDent 基礎版 K221022NextDent 輔助正畸設備 K191497NextDent 牙齒假牙 3D+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。

K261802Glidewell™ 牙托基材膠Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

官方來源

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