FDA 510(k)

CEPHX3D

K 號：K252538 · 2026-03-05

決定日期2026-03-05

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

CEPHX3D is the device name listed in this FDA 510(k) record. The listed applicant is Orca Dental AI , Ltd.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) number K252538. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CEPHX3D?

CEPHX3D is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Orca Dental AI , Ltd.. The 510(k) number is K252538.

When did CEPHX3D receive FDA 510(k) clearance?

CEPHX3D received FDA 510(k) clearance on 2026-03-05, under 510(k) number K252538.

Who is the listed applicant for CEPHX3D?

The FDA 510(k) record lists Orca Dental AI , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEPHX3D?

The FDA product code for CEPHX3D is QIH.

其他以 Orca Dental AI , Ltd. 為申請人之記錄

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相關器械（代碼：QIH）

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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