FDA 510(k)

Paltop 圆锥形植入系統

K 號：K220200 · 2022-05-25

申請人Paltop Advanced Dental Solutions, Ltd.

決定日期2022-05-25

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Paltop Conical 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 2022-05-25 under 510(k) number K220200. 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 Conical Implant System?

Paltop Conical Implant System is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K220200.

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

Paltop Conical Implant System received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220200.

Who is the listed applicant for Paltop Conical 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 Conical Implant System?

The FDA product code for Paltop Conical 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。

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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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