# K994203: Art-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Mar 6, 2000 after 84 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
Longest line of descent: 2 generations back to K950256 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983029: Power Plus 25K Model, S1000, Power Plus 30K Model,S1001, Tpc Advanced Technology, Inc. (1999) Summary page 1.
- K964320: Tony Riso 25/30 Multifunction Scaler, Tony Riso Co., Inc. (1997) Summary page 1.

## Indications for use
The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Source page: https://510kreport.com/device/K994203
Methodology: https://510kreport.com/methodology