# K071981: Bonart Model Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips)

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Oct 26, 2007 after 100 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- 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
ART-P6 Piezo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called “Tip”. Tip comes in various shapes (BS1, BS2, BE3 etc.) and is designed to generate a vibrating frequency of 29K Hz.

Source page: https://510kreport.com/device/K071981
Methodology: https://510kreport.com/methodology