# K113430: Proultra Piezo Ultrasonic

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon Group
- Decided: Feb 23, 2012 after 94 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.
3 later devices descend from it; 3 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132322: Newtron P5 XS B.Led (2014), 0 descendants of its own
- K132267: Newtron P5, Newtron P5 B.Led (2014), 0 descendants of its own
- K131997: Newtron Booster (2013), 0 descendants of its own

## Indications for use
The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with appropriate dental tips for, scaling, periodontics, prosthesis and endodontic Dental Applications.

Source page: https://510kreport.com/device/K113430
Methodology: https://510kreport.com/methodology