FDA 510(k)

Bonart牙科手持工具（ART），一次性噴砂角（PROFORMANCE）

K 號：K162856 · 2017-07-18

決定日期2017-07-18

產品代碼EGS

諮詢委員會DE

決定相當於

器材摘要

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) is the device name listed in this FDA 510(k) record. The listed applicant is Bonart Co., Ltd.. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K162856. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)?

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Bonart Co., Ltd.. The 510(k) number is K162856.

When did Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) receive FDA 510(k) clearance?

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) received FDA 510(k) clearance on 2017-07-18, under 510(k) number K162856.

Who is the listed applicant for Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)?

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

What is the FDA product code for Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)?

The FDA product code for Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) is EGS.

其他以 Bonart Co., Ltd. 為申請人之記錄

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K152125口腔外科系統及附件

相關器械（代碼：EGS）

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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官方來源

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