FDA 510(k)

超印牙科臨時冠與橋UV

K 號：K213643 · 2022-01-14

決定日期2022-01-14

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

UltraPrint-Dental Temp C&B 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 2022-01-14 under 510(k) number K213643. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraPrint-Dental Temp C&B UV?

UltraPrint-Dental Temp C&B UV is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K213643.

When did UltraPrint-Dental Temp C&B UV receive FDA 510(k) clearance?

UltraPrint-Dental Temp C&B UV received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213643.

Who is the listed applicant for UltraPrint-Dental Temp C&B 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 Temp C&B UV?

The FDA product code for UltraPrint-Dental Temp C&B UV is EBG.

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 K253324超印牙科假牙紫外線

相關器械（代碼：EBG）

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。

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基座”及“FLNT 溫度”Liaoning Upcera Co., Ltd.K251271TempFIT 暫時冠橋膠Rizhao Huge Biomaterials Company, Ltd.K243370牙齒牙齒Asiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação K243951TEMP MASTER，基於PMMA的牙科树脂Taiwan Dental Materials Co., Ltd.

官方來源

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