FDA 510(k)

NextDent 牙齒假牙，E-牙齒假牙

K 號：K162572 · 2017-06-30

決定日期2017-06-30

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

NextDent Denture, E-Denture 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 2017-06-30 under 510(k) number K162572. 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, E-Denture?

NextDent Denture, E-Denture is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Vertex-Dental B.V.. The 510(k) number is K162572.

When did NextDent Denture, E-Denture receive FDA 510(k) clearance?

NextDent Denture, E-Denture received FDA 510(k) clearance on 2017-06-30, under 510(k) number K162572.

Who is the listed applicant for NextDent Denture, E-Denture?

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, E-Denture?

The FDA product code for NextDent Denture, E-Denture 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。

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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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