FDA 510(k)

Freeprint® 齿齒套柔軟版

K 號：K252430 · 2025-10-30

決定日期2025-10-30

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Freeprint® denture flex is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252430. 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 Freeprint® denture flex?

Freeprint® denture flex is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Detax GmbH. The 510(k) number is K252430.

When did Freeprint® denture flex receive FDA 510(k) clearance?

Freeprint® denture flex received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252430.

Who is the listed applicant for Freeprint® denture flex?

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

What is the FDA product code for Freeprint® denture flex?

The FDA product code for Freeprint® denture flex is EBI.

其他以 Detax 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。

K232448FREEPRINT® 補片專家 K222877免費打印王

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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