FDA 510(k)

假牙基座膠質 DT20

K 號：K250946 · 2025-03-31

申請人Hangzhou SHINING3D Dental Technology Co., Ltd.

決定日期2025-03-31

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Denture Base Resin DT20 is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou SHINING3D Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-31 under 510(k) number K250946. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Denture Base Resin DT20?

Denture Base Resin DT20 is a medical device that received FDA 510(k) clearance on 2025-03-31. The listed applicant is Hangzhou SHINING3D Dental Technology Co., Ltd.. The 510(k) number is K250946.

When did Denture Base Resin DT20 receive FDA 510(k) clearance?

Denture Base Resin DT20 received FDA 510(k) clearance on 2025-03-31, under 510(k) number K250946.

Who is the listed applicant for Denture Base Resin DT20?

The FDA 510(k) record lists Hangzhou SHINING3D Dental Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denture Base Resin DT20?

The FDA product code for Denture Base Resin DT20 is EBI.

其他以 Hangzhou SHINING3D Dental Technology 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。

K261356Dura-Crown K261261Dura-Arch K260170LumiCera K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

相關器械（代碼：EBI）

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。

K261802Glidewell™ 牙托基材膠Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

官方來源

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