FDA 510(k)

Elos精準客製式牙根台

K 號：K222044 · 2022-11-30

決定日期2022-11-30

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

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 2022-11-30 under 510(k) number K222044. 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 Customized Abutment?

Elos Accurate Customized Abutment is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K222044.

When did Elos Accurate Customized Abutment receive FDA 510(k) clearance?

Elos Accurate Customized Abutment received FDA 510(k) clearance on 2022-11-30, under 510(k) number K222044.

Who is the listed applicant for 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 Customized Abutment?

The FDA product code for 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™K241722Elos Accurate®雙模組基座™；Elos Accurate®客製化牙托 K231307Elos精準客製式牙根台 K230317Elos精準雙模組基座

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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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