FDA 510(k)

超印牙科假牙紫外線

K 號：K253324 · 2025-11-20

決定日期2025-11-20

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

UltraPrint-Dental Denture UV is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253324. 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 UltraPrint-Dental Denture UV?

UltraPrint-Dental Denture UV is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K253324.

When did UltraPrint-Dental Denture UV receive FDA 510(k) clearance?

UltraPrint-Dental Denture UV received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253324.

Who is the listed applicant for UltraPrint-Dental Denture UV?

FDA 510(k) 記錄將廣州海吉爾IMC，有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for UltraPrint-Dental Denture UV?

The FDA product code for UltraPrint-Dental Denture UV is EBI.

其他以 Guangzhou Heygears IMC., Inc. 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。

K261626超印柔軟假牙紫外線 K253798超印牙科硬式護牙套紫外線 K213643超印牙科臨時冠與橋UV

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

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。