# K260773: Varios Combi Pro2

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Mar 10, 2026 after 1 day
- 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: 6 generations back to K900709 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One, E.M.S Electro Medical Systems S.A (2019) Summary page 5.

## Indications for use
The dental device is intended for the following application(s): [Tooth Polishing System] Removal of supragingival and subgingival accretions and deposits, and accretions and deposits on prostheses (including implants). [Ultrasonic Scalers] Removal of accretions and deposits from the surface of teeth and dental restorations (fillings and prostheses), finishing (preparation and adjustment/polishing), removal and cleaning of infected dental tissues, and root canal preparation.

Source page: https://510kreport.com/device/K260773
Methodology: https://510kreport.com/methodology