# K083059: Air Sonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Dpm USA Corp.
- Decided: Jan 30, 2009 after 108 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: 1 generation back to K901488 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901488: Lynx-SM, Sclaer Dental Handpiece, Mti Precision Products (1990) Summary page 1.

## Indications for use
The intended use of the Air Sonic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.

Source page: https://510kreport.com/device/K083059
Methodology: https://510kreport.com/methodology