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FDA 510(k)

帕爾托普窄型植入體

K 號:K210117 · 2021-11-30

決定日期2021-11-30
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

Paltop Narrow Implant is the device name listed in this FDA 510(k) record. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2021-11-30 under 510(k) number K210117. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Paltop Narrow Implant?

Paltop Narrow Implant is a medical device that received FDA 510(k) clearance on 2021-11-30. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K210117.

When did Paltop Narrow Implant receive FDA 510(k) clearance?

Paltop Narrow Implant received FDA 510(k) clearance on 2021-11-30, under 510(k) number K210117.

Who is the listed applicant for Paltop Narrow Implant?

The FDA 510(k) record lists Paltop Advanced Dental Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paltop Narrow Implant?

The FDA product code for Paltop Narrow Implant is DZE.

相關臨床試驗

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。

其他以 Paltop Advanced Dental Solutions, Ltd. 為申請人之記錄

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。

相關器械(代碼:DZE)

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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