FDA 510(k)

BB Base 3D 印刷膠膠水用於假牙基座

K 號：K191591 · 2020-08-18

決定日期2020-08-18

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

BB Base 3D printing resin for denture base 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 2020-08-18 under 510(k) number K191591. 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 BB Base 3D printing resin for denture base?

BB Base 3D printing resin for denture base is a medical device that received FDA 510(k) clearance on 2020-08-18. The listed applicant is Enlighten Materials Co., Ltd.. The 510(k) number is K191591.

When did BB Base 3D printing resin for denture base receive FDA 510(k) clearance?

BB Base 3D printing resin for denture base received FDA 510(k) clearance on 2020-08-18, under 510(k) number K191591.

Who is the listed applicant for BB Base 3D printing resin for denture base?

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 BB Base 3D printing resin for denture base?

The FDA product code for BB Base 3D printing resin for denture base is EBI.

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。

K191590AA 暫時性修復 3D 打印光敏性樹脂

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。

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官方來源

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