FDA 510(k)

數位X光牙科DentiMax Pro影像系統

K 號：K251206 · 2025-09-24

決定日期2025-09-24

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

Digital X-Ray DentiMax Pro Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Dentimax, Inc.. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K251206. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital X-Ray DentiMax Pro Imaging System?

Digital X-Ray DentiMax Pro Imaging System is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Dentimax, Inc.. The 510(k) number is K251206.

When did Digital X-Ray DentiMax Pro Imaging System receive FDA 510(k) clearance?

Digital X-Ray DentiMax Pro Imaging System received FDA 510(k) clearance on 2025-09-24, under 510(k) number K251206.

Who is the listed applicant for Digital X-Ray DentiMax Pro Imaging System?

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

What is the FDA product code for Digital X-Ray DentiMax Pro Imaging System?

The FDA product code for Digital X-Ray DentiMax Pro Imaging System is MUH.

其他以 Dentimax, Inc. 為申請人之記錄

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K220556開感器X系列

相關器械（代碼：MUH）

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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