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FDA 510(k)

陶瓷牙弓絲正畸器

K 號:K222847 · 2023-05-04

決定日期2023-05-04
產品代碼NJM
諮詢委員會DE
決定相當於

器材摘要

Ceramic Brackets Orthometric is the device name listed in this FDA 510(k) record. The listed applicant is Orthometric - Industria E Comercio DE Produtos Medicos. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K222847. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ceramic Brackets Orthometric?

Ceramic Brackets Orthometric is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Orthometric - Industria E Comercio DE Produtos Medicos. The 510(k) number is K222847.

When did Ceramic Brackets Orthometric receive FDA 510(k) clearance?

Ceramic Brackets Orthometric received FDA 510(k) clearance on 2023-05-04, under 510(k) number K222847.

Who is the listed applicant for Ceramic Brackets Orthometric?

The FDA 510(k) record lists Orthometric - Industria E Comercio DE Produtos Medicos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramic Brackets Orthometric?

The FDA product code for Ceramic Brackets Orthometric is NJM.

相關臨床試驗

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相關器械(代碼:NJM)

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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