FDA 510(k)

Bonafix 假牙基座

K 號：K251294 · 2025-10-15

決定日期2025-10-15

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Bonafix Implant Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Zentek Medical, LLC. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K251294. 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 Bonafix Implant Abutments?

Bonafix Implant Abutments is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Zentek Medical, LLC. The 510(k) number is K251294.

When did Bonafix Implant Abutments receive FDA 510(k) clearance?

Bonafix Implant Abutments received FDA 510(k) clearance on 2025-10-15, under 510(k) number K251294.

Who is the listed applicant for Bonafix Implant Abutments?

The FDA 510(k) record lists Zentek Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bonafix Implant Abutments?

The FDA product code for Bonafix Implant Abutments is NHA.

其他以 Zentek Medical, LLC 為申請人之記錄

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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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