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FDA 510(k)

VITA VMLC 基質

K 號:K251587 · 2026-02-23

決定日期2026-02-23
產品代碼KLE
諮詢委員會DE
決定相當於

器材摘要

VITA VMLC Primer is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K251587. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITA VMLC Primer?

VITA VMLC Primer is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. The 510(k) number is K251587.

When did VITA VMLC Primer receive FDA 510(k) clearance?

VITA VMLC Primer received FDA 510(k) clearance on 2026-02-23, under 510(k) number K251587.

Who is the listed applicant for VITA VMLC Primer?

The FDA 510(k) record lists Vita Zahnfabrik H. Rauter GmbH & Co. Kg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA VMLC Primer?

The FDA product code for VITA VMLC Primer is KLE.

相關臨床試驗

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相關器械(代碼:KLE)

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。

官方來源

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