FDA 510(k)

JET咬傷；JET藍咬傷快速；JET藍咬傷超快速

K 號：K250969 · 2025-06-27

決定日期2025-06-27

產品代碼ELW

諮詢委員會DE

決定相當於

器材摘要

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is the device name listed in this FDA 510(k) record. The listed applicant is Dent4you AG. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K250969. 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 JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Dent4you AG. The 510(k) number is K250969.

When did JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST receive FDA 510(k) clearance?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST received FDA 510(k) clearance on 2025-06-27, under 510(k) number K250969.

Who is the listed applicant for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

The FDA 510(k) record lists Dent4you AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

The FDA product code for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is ELW.

其他以 Dent4you AG 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。

K242360Speedex 輕型身體；Speedex 中型；Speedex 黏土；Speedex 黏土軟；Speedex 適用型活化工具 K240801BioSonic US200 超聲波刮牙器 (60034537)K223142Coltolux舒適LED固化燈

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。

K254152Dia-X Sil Light BodyDiaDent Group International K254142Dia-X Sil Heavy BodyDiaDent Group International K254112迪亞-X 靜脈針DiaDent Group International K253501Hydro 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 Ltda K241924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。