FDA 510(k)

Nobilplast 牙齒假牙膠

K 號：K170375 · 2017-10-02

決定日期2017-10-02

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Nobilplast Denture Resin is the device name listed in this FDA 510(k) record. The listed applicant is Cmp Industries, LLC. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K170375. 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 Nobilplast Denture Resin?

Nobilplast Denture Resin is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Cmp Industries, LLC. The 510(k) number is K170375.

When did Nobilplast Denture Resin receive FDA 510(k) clearance?

Nobilplast Denture Resin received FDA 510(k) clearance on 2017-10-02, under 510(k) number K170375.

Who is the listed applicant for Nobilplast Denture Resin?

The FDA 510(k) record lists Cmp Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nobilplast Denture Resin?

The FDA product code for Nobilplast Denture Resin is EBI.

其他以 Cmp Industries, LLC 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。

K170423牙套識別微晶片

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。