FDA 510(k)

迪亞泰普流

K 號：K192022 · 2020-02-13

決定日期2020-02-13

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

DiaTemp Flow is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192022. 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 DiaTemp Flow?

DiaTemp Flow is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is DiaDent Group International. The 510(k) number is K192022.

When did DiaTemp Flow receive FDA 510(k) clearance?

DiaTemp Flow received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192022.

Who is the listed applicant for DiaTemp Flow?

FDA 510(k) 記錄將 DiaDent Group International 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for DiaTemp Flow?

The FDA product code for DiaTemp Flow is EBG.

其他以 DiaDent Group International 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。

K254152Dia-X Sil Light Body K254142Dia-X Sil Heavy Body K261166DIA-CEM K261093DIAFIL K261071DIAFIL 大量流量（經濟包裝）；DIAFIL 大量流量（補充包裝）；DIAFIL 大量流量（0.5g）K254112迪亞-X 靜脈針

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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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