免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

圖像快速組合，圖像標準組合

K 號：K160097 · 2016-08-05

申請人Sybron Dental Specialties
決定日期2016-08-05
產品代碼ELW
諮詢委員會DE
決定相當於

器材摘要

Image Fast Set, Image Regular Set is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K160097. 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 Image Fast Set, Image Regular Set?

Image Fast Set, Image Regular Set is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Sybron Dental Specialties. The 510(k) number is K160097.

When did Image Fast Set, Image Regular Set receive FDA 510(k) clearance?

Image Fast Set, Image Regular Set received FDA 510(k) clearance on 2016-08-05, under 510(k) number K160097.

Who is the listed applicant for Image Fast Set, Image Regular Set?

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

What is the FDA product code for Image Fast Set, Image Regular Set?

The FDA product code for Image Fast Set, Image Regular Set is ELW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Sybron Dental Specialties 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。

K182826Ormco Spark 調整器系統K162063史迪-卡式及史迪-籠消毒包裝系統K153067Tubli-Seal, Tubli-Seal EWT, Tubli-Seal Xpress, Tubli-Seal EWT XpressK152956牙髓管封堵劑，牙髓管封堵劑EWTK152959Sealapex管，Sealapex大量包裝，Sealapex Xpress雙筒針筒

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 InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112迪亞-X 靜脈針DiaDent 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.

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。

↑