迪亞-X 靜脈針
K 號：K254112 · 2026-03-19
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器材摘要
Dia-X Sil Bite 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 2026-03-19 under 510(k) number K254112. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dia-X Sil Bite?
Dia-X Sil Bite is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is DiaDent Group International. The 510(k) number is K254112.
When did Dia-X Sil Bite receive FDA 510(k) clearance?
Dia-X Sil Bite received FDA 510(k) clearance on 2026-03-19, under 510(k) number K254112.
Who is the listed applicant for Dia-X Sil Bite?
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 Dia-X Sil Bite?
The FDA product code for Dia-X Sil Bite is ELW.
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。
相關器械（代碼：ELW）
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。
K254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254152Dia-X Sil Light BodyDiaDent Group InternationalK253501Hydro Print Premium 快速設置 - 454g (1磅) (052037)；Hydro Print Premium 标準設置 - 454g (1磅) (052327)；Chroma Print Premium 快速設置 - 454g (1磅) (052457)；Chroma Print Premium 标準設置 - 454g (1磅) (051460)；Perfil Pro - 454g (1磅) (056213)；Perfil Pro+ - 454g (1磅) (056121)；Perfil Pro Chroma - 454g (1磅) (056122)；Hydro Print Premium 快速設置 - 多包裝 (056205)；Hydro Print Premium 标準設置 - 多包裝 (056208)；Hydro Print Premium 快速設置 - 9,07Kg (20磅) (056204)。Vigodent Indústria E Comercio LtdaK250969JET咬傷；JET藍咬傷快速；JET藍咬傷超快速Dent4you AGK241924彈性印模材質Beijing Okvd Biological Technology , Ltd.K242360Speedex 輕型身體；Speedex 中型；Speedex 黏土；Speedex 黏土軟；Speedex 適用型活化工具Dent4you AG
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。
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