# K042056: AZ Ultrasonic System

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Sep 30, 2004 after 62 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
The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontic or endodontic use.

Source page: https://510kreport.com/device/K042056
Methodology: https://510kreport.com/methodology