FDA 510(k)

HySil Plus 印記材質

K 號：K210041 · 2021-03-18

決定日期2021-03-18

產品代碼ELW

諮詢委員會DE

決定相當於

器材摘要

HySil Plus Impression Materials is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K210041. 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 HySil Plus Impression Materials?

HySil Plus Impression Materials is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K210041.

When did HySil Plus Impression Materials receive FDA 510(k) clearance?

HySil Plus Impression Materials received FDA 510(k) clearance on 2021-03-18, under 510(k) number K210041.

Who is the listed applicant for HySil Plus Impression Materials?

The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HySil Plus Impression Materials?

The FDA product code for HySil Plus Impression Materials is ELW.

其他以 Osstem Implant 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。

K251434治療基座系統 K251569骨釘 K242521Estar-ZE K233806T2 Plus K233194TS牙根支承系統 K232220SS牙根擴張系統

查看所有 31 項裝置 →

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 K250969JET咬傷；JET藍咬傷快速；JET藍咬傷超快速Dent4you AG K241924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。