# K080089: Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument Tips

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Sep 4, 2008 after 234 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 K944714 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033812: Siroair L Air Scaler, Sirona Dental Systems GmbH (2004) Summary page 1.

## Most influential descendants
- K161639: Y-MIC (2016), 0 descendants of its own

## Indications for use
The SONICflex 2003 and SONICflex Lux 2003 L with Instrument Tips are air-powered scalers for use by qualified dental practitioners in the four conventional dental applications of scaling, periodontics, endodontics and prosthesis.

Source page: https://510kreport.com/device/K080089
Methodology: https://510kreport.com/methodology