FDA 510(k)

Neodent金色調定制牙根，Medentika定制牙根金色調

K 號：K260460 · 2026-05-07

決定日期2026-05-07

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K260460. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?

Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Institut Straumann AG. The 510(k) number is K260460.

When did Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue receive FDA 510(k) clearance?

Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue received FDA 510(k) clearance on 2026-05-07, under 510(k) number K260460.

Who is the listed applicant for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?

The FDA product code for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is NHA.

其他以 Institut Straumann AG 為申請人之記錄

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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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