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FDA 510(k)

正畸丙烯酸2

K 號：K163482 · 2017-05-31

申請人Lang Dental Manufacturing Co., Inc.
決定日期2017-05-31
產品代碼EBI
諮詢委員會DE
決定相當於

器材摘要

Orthodontic Acrylic 2 is the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K163482. 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 Orthodontic Acrylic 2?

Orthodontic Acrylic 2 is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Lang Dental Manufacturing Co., Inc.. The 510(k) number is K163482.

When did Orthodontic Acrylic 2 receive FDA 510(k) clearance?

Orthodontic Acrylic 2 received FDA 510(k) clearance on 2017-05-31, under 510(k) number K163482.

Who is the listed applicant for Orthodontic Acrylic 2?

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

What is the FDA product code for Orthodontic Acrylic 2?

The FDA product code for Orthodontic Acrylic 2 is EBI.

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：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

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