FDA 510(k)

LuxCreo 強柔性部分牙托树脂

K 號：K253365 · 2025-11-25

決定日期2025-11-25

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

LuxCreo Flexible Partial Denture Resin is the device name listed in this FDA 510(k) record. The listed applicant is LuxCreo, Inc.. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K253365. 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 LuxCreo Flexible Partial Denture Resin?

LuxCreo Flexible Partial Denture Resin is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is LuxCreo, Inc.. The 510(k) number is K253365.

When did LuxCreo Flexible Partial Denture Resin receive FDA 510(k) clearance?

LuxCreo Flexible Partial Denture Resin received FDA 510(k) clearance on 2025-11-25, under 510(k) number K253365.

Who is the listed applicant for LuxCreo Flexible Partial Denture Resin?

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

What is the FDA product code for LuxCreo Flexible Partial Denture Resin?

The FDA product code for LuxCreo Flexible Partial Denture Resin is EBI.

其他以 LuxCreo, Inc. 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。

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官方來源

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