FDA 510(k)

ET IV SA 牙齒植體

K 號：K183242 · 2019-05-21

決定日期2019-05-21

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

ET IV SA Dental Implants is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K183242. 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 ET IV SA Dental Implants?

ET IV SA Dental Implants is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Hiossen, Inc.. The 510(k) number is K183242.

When did ET IV SA Dental Implants receive FDA 510(k) clearance?

ET IV SA Dental Implants received FDA 510(k) clearance on 2019-05-21, under 510(k) number K183242.

Who is the listed applicant for ET IV SA Dental Implants?

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

What is the FDA product code for ET IV SA Dental Implants?

The FDA product code for ET IV SA Dental Implants is DZE.

其他以 Hiossen, 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。

K253372ET治療基座；ET掃描治療基座；EK掃描治療基座 K251427EK多角度30牙根座 K241003HIOSSEN 預製基座（ET 預製基座 & EK 預製基座）K240232EK D3.3 及超廣角植入體 K233389EK數位牙根支台 K222636ET牙根擴張系統

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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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