FDA 510(k)

DD醫療聚合物（PMMA）

K 號：K230410 · 2023-06-23

決定日期2023-06-23

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

DD medical polymers (PMMA) is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230410. 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 DD medical polymers (PMMA)?

DD medical polymers (PMMA) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Dental Direkt GmbH. The 510(k) number is K230410.

When did DD medical polymers (PMMA) receive FDA 510(k) clearance?

DD medical polymers (PMMA) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230410.

Who is the listed applicant for DD medical polymers (PMMA)?

The FDA 510(k) record lists Dental Direkt GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DD medical polymers (PMMA)?

The FDA product code for DD medical polymers (PMMA) is EBI.

其他以 Dental Direkt GmbH 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。

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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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