# K162856: Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)

- Pathway: 510(k) (Abbreviated)
- Applicant: Bonart Co., Ltd.
- Decided: Jul 18, 2017 after 279 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Bonart dental hand piece is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures. restorations.

Source page: https://510kreport.com/device/K162856
Methodology: https://510kreport.com/methodology