# K042872: Rondoflex Plus 360

- Pathway: 510(k) (Special)
- Applicant: Kavo America Corporation
- Decided: Nov 23, 2004 after 36 days
- Product code: KOJ (Airbrush)
- Device class: 2
- Regulation: 21 CFR 872.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900709 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002708: Kavo Corund Handpiece 2013, Kavo America (2000) Summary page 1.
- K024105: Velopex Aquacut Fluid Abrasion Unit, Velopex International, Inc. (2003) Summary page 1.
- K033675: Prosmile Air Polisher and Prophylaxis Powder, Sirona Dental Systems GmbH (2004) Summary page 1.

## Indications for use
The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.

Source page: https://510kreport.com/device/K042872
Methodology: https://510kreport.com/methodology