FDA 510(k)

Elos Accurate®雙模組基座™；Elos Accurate®客製化牙托

K 號：K241722 · 2024-09-13

決定日期2024-09-13

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K241722. 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 Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K241722.

When did Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment receive FDA 510(k) clearance?

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment received FDA 510(k) clearance on 2024-09-13, under 510(k) number K241722.

Who is the listed applicant for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

The FDA product code for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is NHA.

其他以 Elos Medtech Pinol A/S 為申請人之記錄

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K253774Elos Accurate® 牙齒固定系統 K251497Elos精準雙模組基座 K242025Elos Accurate®雙模組基座™K231307Elos精準客製式牙根台 K230317Elos精準雙模組基座 K222044Elos精準客製式牙根台

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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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