FDA 510(k)

P pro 頸冠橋

K 號：K200039 · 2020-07-31

決定日期2020-07-31

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

P pro Crown & Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K200039. 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 P pro Crown & Bridge?

P pro Crown & Bridge is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Deltamed GmbH. The 510(k) number is K200039.

When did P pro Crown & Bridge receive FDA 510(k) clearance?

P pro Crown & Bridge received FDA 510(k) clearance on 2020-07-31, under 510(k) number K200039.

Who is the listed applicant for P pro Crown & Bridge?

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

What is the FDA product code for P pro Crown & Bridge?

The FDA product code for P pro Crown & Bridge is EBG.

其他以 Deltamed 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。

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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

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