FDA 510(k)

Bonart Dental 手持机 (ART), 一次性抛光角度 (PROFORMANCE)

K号: K162856 · 2017-07-18

决定日期2017-07-18

产品代码EGS

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决定实质等同

器械摘要

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.

常见问题

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.

列明Bonart Co., Ltd.为申报人的其他记录

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