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FDA 510(k)

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)

K-Number: K162856 · 2017-07-18

ApplicantBonart Co., Ltd.
Decision Date2017-07-18
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Bonart Co., Ltd.. The 510(k) number is K162856.

When was Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) approved by the FDA?

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

What company makes Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)?

Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) is manufactured by Bonart Co., Ltd..

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.

Related Clinical Trials

NCT06308640 Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography ACTIVE_NOT_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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