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FDA 510(k)

AA 暫時性修復 3D 打印光敏性樹脂

K 號：K191590 · 2020-05-05

申請人Enlighten Materials Co., Ltd.
決定日期2020-05-05
產品代碼EBG
諮詢委員會DE
決定相當於

器材摘要

AA temp temporary restoration 3D printing photoreactive resin is the device name listed in this FDA 510(k) record. The listed applicant is Enlighten Materials Co., Ltd.. It received FDA 510(k) clearance on 2020-05-05 under 510(k) number K191590. 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 AA temp temporary restoration 3D printing photoreactive resin?

AA temp temporary restoration 3D printing photoreactive resin is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is Enlighten Materials Co., Ltd.. The 510(k) number is K191590.

When did AA temp temporary restoration 3D printing photoreactive resin receive FDA 510(k) clearance?

AA temp temporary restoration 3D printing photoreactive resin received FDA 510(k) clearance on 2020-05-05, under 510(k) number K191590.

Who is the listed applicant for AA temp temporary restoration 3D printing photoreactive resin?

The FDA 510(k) record lists Enlighten Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AA temp temporary restoration 3D printing photoreactive resin?

The FDA product code for AA temp temporary restoration 3D printing photoreactive resin is EBG.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Enlighten Materials 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。

K191591BB Base 3D 印刷膠膠水用於假牙基座

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 ExportaçãoK243951TEMP MASTER，基於PMMA的牙科树脂Taiwan Dental Materials Co., Ltd.

官方來源

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