FDA 510(k)

GenesisZr™ 4Y 齒鹼

K 號：K182642 · 2019-01-25

決定日期2019-01-25

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

GenesisZr™ 4Y Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is United Dental Resources Corporation. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K182642. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GenesisZr™ 4Y Zirconia?

GenesisZr™ 4Y Zirconia is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is United Dental Resources Corporation. The 510(k) number is K182642.

When did GenesisZr™ 4Y Zirconia receive FDA 510(k) clearance?

GenesisZr™ 4Y Zirconia received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182642.

Who is the listed applicant for GenesisZr™ 4Y Zirconia?

The FDA 510(k) record lists United Dental Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenesisZr™ 4Y Zirconia?

The FDA product code for GenesisZr™ 4Y Zirconia is EIH.

其他以 United Dental Resources Corporation 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。

K201915GenesisZr 4Y+ (ST1100) 鈇化鋁 K201608GenesisZr UHT700 鈇化鎵

相關器械（代碼：EIH）

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。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

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。