# K061448: Bonart Art-P3II & P4 Piezo Electric Ultrasonic Scaler Units with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Aug 17, 2006 after 87 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
BONART's ART-P311 & ART-P4 Piezo Ultrasonic Scaler are 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". Tips come in various shapes (ESI, BS2, BS3 etc.) and are designed to generate a vibrating frequency of 29Khz.

Source page: https://510kreport.com/device/K061448
Methodology: https://510kreport.com/methodology