FDA 510(k)

URIS智慧導管植入系統及義肢

K 號：K230438 · 2023-12-29

決定日期2023-12-29

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

URIS Smart Path Implant System & Prosthetic is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K230438. 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 URIS Smart Path Implant System & Prosthetic?

URIS Smart Path Implant System & Prosthetic is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Truabutment, Inc.. The 510(k) number is K230438.

When did URIS Smart Path Implant System & Prosthetic receive FDA 510(k) clearance?

URIS Smart Path Implant System & Prosthetic received FDA 510(k) clearance on 2023-12-29, under 510(k) number K230438.

Who is the listed applicant for URIS Smart Path Implant System & Prosthetic?

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

What is the FDA product code for URIS Smart Path Implant System & Prosthetic?

The FDA product code for URIS Smart Path Implant System & Prosthetic is DZE.

其他以 Truabutment, Inc. 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。

K243255URIS長期植入體與基座 K241485TruAbutment DS; TruBase K231874AOT & T-L 套管 K213961TruAbutment DS, TruBase K203649TruAbutment DS, TruBase K202579TruAbutment DS, TruBase

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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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