FDA 510(k)

Paltop 牙齒植體系統

K 號：K243983 · 2025-09-29

申請人Paltop Advanced Dental Solutions, Ltd.

決定日期2025-09-29

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Paltop Dental Implant System 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 2025-09-29 under 510(k) number K243983. 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 Dental Implant System?

Paltop Dental Implant System is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K243983.

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

Paltop Dental Implant System received FDA 510(k) clearance on 2025-09-29, under 510(k) number K243983.

Who is the listed applicant for Paltop Dental Implant System?

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 Dental Implant System?

The FDA product code for Paltop Dental Implant System is DZE.

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。

K232740Paltop 短植入體 K220200Paltop 圆锥形植入系統 K210117帕爾托普窄型植入體

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。

K261392三活牙植體系統Paragon Implant Mfg., LLC K260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

官方來源

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