FDA 510(k)

SDS1.2 齿植體

K 號：K181953 · 2019-11-20

決定日期2019-11-20

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

SDS1.2 dental implant is the device name listed in this FDA 510(k) record. The listed applicant is Sds Swiss Dental Solutions AG. It received FDA 510(k) clearance on 2019-11-20 under 510(k) number K181953. 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 SDS1.2 dental implant?

SDS1.2 dental implant is a medical device that received FDA 510(k) clearance on 2019-11-20. The listed applicant is Sds Swiss Dental Solutions AG. The 510(k) number is K181953.

When did SDS1.2 dental implant receive FDA 510(k) clearance?

SDS1.2 dental implant received FDA 510(k) clearance on 2019-11-20, under 510(k) number K181953.

Who is the listed applicant for SDS1.2 dental implant?

The FDA 510(k) record lists Sds Swiss Dental Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDS1.2 dental implant?

The FDA product code for SDS1.2 dental implant is DZE.

其他以 Sds Swiss Dental Solutions AG 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。

K190406SDS2.2 牙齒植體

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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