FDA 510(k)

VSP系統（鈦金顎板牙橋）

K 號：K261826 · 2026-06-03

決定日期2026-06-03

產品代碼DZJ

諮詢委員會DE

決定相當於

器材摘要

VSP System (Titanium Palatal Splint) is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261826. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VSP System (Titanium Palatal Splint)?

VSP System (Titanium Palatal Splint) is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is 3D Systems, Inc.. The 510(k) number is K261826.

When did VSP System (Titanium Palatal Splint) receive FDA 510(k) clearance?

VSP System (Titanium Palatal Splint) received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261826.

Who is the listed applicant for VSP System (Titanium Palatal Splint)?

The FDA 510(k) record lists 3D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSP System (Titanium Palatal Splint)?

The FDA product code for VSP System (Titanium Palatal Splint) is DZJ.

其他以 3D Systems, Inc. 為申請人之記錄

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相關器械（代碼：DZJ）

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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