FDA 510(k)

Atlantis® Abutments in Titanium

K 號：K252343 · 2025-12-09

決定日期2025-12-09

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Atlantis® Abutments in Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K252343. 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 Atlantis® Abutments in Titanium?

Atlantis® Abutments in Titanium is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Dentsply Sirona. The 510(k) number is K252343.

When did Atlantis® Abutments in Titanium receive FDA 510(k) clearance?

Atlantis® Abutments in Titanium received FDA 510(k) clearance on 2025-12-09, under 510(k) number K252343.

Who is the listed applicant for Atlantis® Abutments in Titanium?

FDA 510(k) 記錄將 Dentsply Sirona 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Atlantis® Abutments in Titanium?

The FDA product code for Atlantis® Abutments in Titanium is NHA.

其他以 Dentsply Sirona 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：NHA）

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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