FDA 510(k)

超印牙科硬式護牙套紫外線

K 號：K253798 · 2026-03-02

決定日期2026-03-02

產品代碼MQC

決定相當於

器材摘要

UltraPrint-Dental Hard Splint 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 2026-03-02 under 510(k) number K253798. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraPrint-Dental Hard Splint UV?

UltraPrint-Dental Hard Splint UV is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K253798.

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

UltraPrint-Dental Hard Splint UV received FDA 510(k) clearance on 2026-03-02, under 510(k) number K253798.

Who is the listed applicant for UltraPrint-Dental Hard Splint 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 Hard Splint UV?

The FDA product code for UltraPrint-Dental Hard Splint UV is MQC.

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 K253324超印牙科假牙紫外線 K213643超印牙科臨時冠與橋UV

相關器械（代碼：MQC）

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。

K250743Remvia 夜間護牙器Remvia K251252NOBILCAM 輻射盤Shandong Huge Dental Material Corporation K241729硬式支具 & 適應性熱療支具Whip Mix Corporation K243516Remi 訂製夜間護牙器Grindguard, Inc.K241369麗家夜護牙套Lijia, LLC K231775GR膠質系統 MSIPro3Dure Medical

官方來源

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