FDA 510(k)

Neodent植牙系統-NGM精簡外科技術套件盒

K 號：K214051 · 2022-04-13

申請人JJGC Indústria e Comércio de Materiais Dentários S.A.

決定日期2022-04-13

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Neodent Implant System-Helix NGM Compact Surgical Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K214051. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent Implant System-Helix NGM Compact Surgical Kit Cases?

Neodent Implant System-Helix NGM Compact Surgical Kit Cases is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K214051.

When did Neodent Implant System-Helix NGM Compact Surgical Kit Cases receive FDA 510(k) clearance?

Neodent Implant System-Helix NGM Compact Surgical Kit Cases received FDA 510(k) clearance on 2022-04-13, under 510(k) number K214051.

Who is the listed applicant for Neodent Implant System-Helix NGM Compact Surgical Kit Cases?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Implant System-Helix NGM Compact Surgical Kit Cases?

The FDA product code for Neodent Implant System-Helix NGM Compact Surgical Kit Cases is KCT.

其他以 JJGC Indústria e Comércio de Materiais Dentários S.A. 為申請人之記錄

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相關器械（代碼：KCT）

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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