# K033198: Apoza Ultrasonic Scaler and Edodontics Unit, Selector U2

- Pathway: 510(k) (Traditional)
- Applicant: Apoza Enterprise Co., Ltd.
- Decided: Apr 30, 2004 after 211 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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) Summary page 1.

## Indications for use
The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth or clean the root canal (with endo-kit) in the prophylaxis procedures. The device carries the following label: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Source page: https://510kreport.com/device/K033198
Methodology: https://510kreport.com/methodology