FDA 510(k)

PrimeTaper EV 齒齒植體

K 號：K210610 · 2021-08-27

決定日期2021-08-27

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

PrimeTaper EV Dental Implant is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210610. 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 PrimeTaper EV Dental Implant?

PrimeTaper EV Dental Implant is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K210610.

When did PrimeTaper EV Dental Implant receive FDA 510(k) clearance?

PrimeTaper EV Dental Implant received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210610.

Who is the listed applicant for PrimeTaper EV Dental Implant?

FDA 510(k) 記錄將 Dentsply Sirona, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PrimeTaper EV Dental Implant?

The FDA product code for PrimeTaper EV Dental Implant is DZE.

其他以 Dentsply Sirona, Inc. 為申請人之記錄

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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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