FDA 510(k)

E-Temp

K 號：K211101 · 2021-06-14

決定日期2021-06-14

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

E-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-06-14 under 510(k) number K211101. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the E-Temp?

E-Temp is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Envisiontec GmbH. The 510(k) number is K211101.

When did E-Temp receive FDA 510(k) clearance?

E-Temp received FDA 510(k) clearance on 2021-06-14, under 510(k) number K211101.

Who is the listed applicant for E-Temp?

The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Temp?

The FDA product code for E-Temp is EBG.

其他以 Envisiontec GmbH 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。

K220894SmileGuard K210977E-Dent 1000 K203641E-Denture Pro K201173E-Guard

相關器械（代碼：EBG）

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。

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基座”及“FLNT 溫度”Liaoning Upcera Co., Ltd.K251271TempFIT 暫時冠橋膠Rizhao Huge Biomaterials Company, Ltd.K243370牙齒牙齒Asiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação K243951TEMP MASTER，基於PMMA的牙科树脂Taiwan Dental Materials Co., Ltd.

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。