# K994299: Art-P3, Model P3-1-Art-A1

- Pathway: 510(k) (Traditional)
- Applicant: Bonart Co., Ltd.
- Decided: Mar 6, 2000 after 76 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 K942139 (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)
- K961158: Suprasson P5 Booster, Satelec (1996). Our OCR of the scanned summary read K961358, FDA’s number for Arrow Sheathless Intra-Aortic Balloon Catheter (Arrow Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SUPRASSON P5 Booster”.
- K953026: Minipiezon, Electro Medical Systems SA (1995) 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/K994299
Methodology: https://510kreport.com/methodology