# K223173: Proxeo ULTRA (PB-510, PB-520 and PB-530)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoss GmbH
- Decided: Jul 14, 2023 after 276 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: 7 generations back to K896749 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140965: Multipiezo Pro, Multipiezo, Mectron S.P.A. (2014) Summary page 5.

## Indications for use
Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation. The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

Source page: https://510kreport.com/device/K223173
Methodology: https://510kreport.com/methodology