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FDA 510(k)

PackFil雙固化膠粘劑改進型玻璃離子鹽修復水泥

K 號：K152652 · 2016-04-05

申請人Gaia Dental Products, Inc.
決定日期2016-04-05
產品代碼EMA
諮詢委員會DE
決定相當於

器材摘要

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is the device name listed in this FDA 510(k) record. The listed applicant is Gaia Dental Products, Inc.. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K152652. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Gaia Dental Products, Inc.. The 510(k) number is K152652.

When did PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement receive FDA 510(k) clearance?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement received FDA 510(k) clearance on 2016-04-05, under 510(k) number K152652.

Who is the listed applicant for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

The FDA 510(k) record lists Gaia Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

The FDA product code for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is EMA.

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

相關器械（代碼：EMA）

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。

K262983EsTemp 偽裝體Spident Co., Ltd.K254201任何-瓷Mediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM 大眾化GC America, Inc.K253337REGEN 生物活性水泥Inter-Med, Inc.

官方來源

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