Cleared Abbreviated

K162856 - Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (FDA 510(k) Clearance)

Class I Dental device.

K162856 · Bonart Co., Ltd. · Dental device
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Jul 2017
Decision
279d
Days
Class 1
Risk

K162856 is an FDA 510(k) clearance for the Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE). Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Bonart Co., Ltd. (Keelung City, TW). The FDA issued a Cleared decision on July 18, 2017 after a review of 279 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bonart Co., Ltd. devices

Submission Details

510(k) Number K162856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2016
Decision Date July 18, 2017
Days to Decision 279 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 127d · This submission: 279d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
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