# K020080: Bonart Art-E1 Electrosurgery Unit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Data, Inc.
- Decided: Feb 19, 2002 after 41 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K213477: Root ZX3 (2022), 0 descendants of its own

## Indications for use
The Bonart Co., Ltd. ART-E1 Electrosurgery Unit is intended for use in dental electrosurgery (electrosection), - electrosection/electrocoagulation, and electrocoagulation for serious bleeding.

Source page: https://510kreport.com/device/K020080
Methodology: https://510kreport.com/methodology