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FDA 510(k)

維爾美尼牙醫用設備(V4D)牙髓牙周

K 號:K252953 · 2026-05-11

申請人Velmeni, Inc.
決定日期2026-05-11
產品代碼MYN
諮詢委員會RA
決定相當於

器材摘要

Velmeni for Dentists (V4D) Endo-Perio is the device name listed in this FDA 510(k) record. The listed applicant is Velmeni, Inc.. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K252953. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Velmeni for Dentists (V4D) Endo-Perio?

Velmeni for Dentists (V4D) Endo-Perio is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Velmeni, Inc.. The 510(k) number is K252953.

When did Velmeni for Dentists (V4D) Endo-Perio receive FDA 510(k) clearance?

Velmeni for Dentists (V4D) Endo-Perio received FDA 510(k) clearance on 2026-05-11, under 510(k) number K252953.

Who is the listed applicant for Velmeni for Dentists (V4D) Endo-Perio?

FDA 510(k) 記錄將 Velmeni, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Velmeni for Dentists (V4D) Endo-Perio?

The FDA product code for Velmeni for Dentists (V4D) Endo-Perio is MYN.

相關臨床試驗

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其他以 Velmeni, 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。

相關器械(代碼:MYN)

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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