Hexa-Temp
K 號：K214071 · 2022-03-10
廣告
器材摘要
Hexa-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K214071. 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 Hexa-Temp?
Hexa-Temp is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Spident Co., Ltd.. The 510(k) number is K214071.
When did Hexa-Temp receive FDA 510(k) clearance?
Hexa-Temp received FDA 510(k) clearance on 2022-03-10, under 510(k) number K214071.
Who is the listed applicant for Hexa-Temp?
FDA 510(k) 記錄將 Spident Co., Ltd. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Hexa-Temp?
The FDA product code for Hexa-Temp is EBG.
其他以 Spident Co., Ltd. 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。
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 ExportaçãoK243951TEMP 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。
廣告