FDA 510(k)

RODIN 鐵砲3D膠質

K 號：K240688 · 2024-06-20

決定日期2024-06-20

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

RODIN Titan 3D Resin is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240688. 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 RODIN Titan 3D Resin?

RODIN Titan 3D Resin is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K240688.

When did RODIN Titan 3D Resin receive FDA 510(k) clearance?

RODIN Titan 3D Resin received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240688.

Who is the listed applicant for RODIN Titan 3D Resin?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Titan 3D Resin?

The FDA product code for RODIN Titan 3D Resin is EBI.

其他以 Belport Company, Inc., Gingi-Pak 為申請人之記錄

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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。

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官方來源

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