# K042972: XP Technology Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: American Eagle Instruments, Inc.
- Decided: Mar 18, 2005 after 141 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. The FDA summary names no predicate by number.

## Indications for use
An ultrasonic scaling system is used by dental professionals as a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. This device is contraindicated for children and adults with synthetic teeth This device should not be used on patients or by users who have a pacemaker

Source page: https://510kreport.com/device/K042972
Methodology: https://510kreport.com/methodology