# K081550: Bonart Ultrasonic Scaler, Moedls Art-P3II Pro and Art-Mii Pro

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Aug 28, 2008 after 86 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-P311 Multi-Function Piezoelectric Ultrasonic System 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, FK3 etc.) and is designed to generate a vibrating frequency of 29Khz. ART-M311 Multi-Function Magnet Ultrasonic System 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 “Insert”. Insert comes in various shapes (ART-10, ART-SLI-P100, ART-IF50 etc.) and is designed to generate a vibrating frequency

Source page: https://510kreport.com/device/K081550
Methodology: https://510kreport.com/methodology