FDA 510(k)

FORMA複合材（顏色A3D）

K 號：K240694 · 2024-03-15

決定日期2024-03-15

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

FORMA Composite (Shade A3D) is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K240694. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FORMA Composite (Shade A3D)?

FORMA Composite (Shade A3D) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K240694.

When did FORMA Composite (Shade A3D) receive FDA 510(k) clearance?

FORMA Composite (Shade A3D) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240694.

Who is the listed applicant for FORMA Composite (Shade A3D)?

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

What is the FDA product code for FORMA Composite (Shade A3D)?

The FDA product code for FORMA Composite (Shade A3D) is EBF.

其他以 Ultradent Products, 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：EBF）

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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