FDA 510(k)

A-Silicone for Bite Registration

K 號：K201684 · 2020-09-24

申請人Shandong Huge Dental Material Corporation

決定日期2020-09-24

產品代碼ELW

諮詢委員會DE

決定相當於

器材摘要

A-Silicone for Bite Registration is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2020-09-24 under 510(k) number K201684. 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 A-Silicone for Bite Registration?

A-Silicone for Bite Registration is a medical device that received FDA 510(k) clearance on 2020-09-24. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K201684.

When did A-Silicone for Bite Registration receive FDA 510(k) clearance?

A-Silicone for Bite Registration received FDA 510(k) clearance on 2020-09-24, under 510(k) number K201684.

Who is the listed applicant for A-Silicone for Bite Registration?

The FDA 510(k) record lists Shandong Huge Dental Material Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-Silicone for Bite Registration?

The FDA product code for A-Silicone for Bite Registration is ELW.

其他以 Shandong Huge Dental Material Corporation 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。

K260376假牙基座 K260067永恒藝術瓷粉 K251252NOBILCAM 輻射盤 K220680假牙基座聚合物 K213994彈性塊 K181747正畸設備

查看所有 9 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。