# K231391: Combi Touch

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: May 15, 2023 after 3 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: 6 generations back to K900709 (1990). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 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 6.

## Most influential descendants
- K251425: turbodent touch (2025), 0 descendants of its own

## Indications for use
combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit. Ultrasonic scaler function: combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications: * Removing supra and subgingival calculus deposits and stains from teeth * Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement » Scaling and root planing * Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha » Plugging for amalgam condensation * Amalgam burnishing * Preparing, cleaning and irrigating roots canals * Cavity preparation * Cleaning restorations and implant surfaces Air-polishing prophylaxis function: By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. combi touch is intended for the following oral prophylaxis procedures: * Plaque removal for placement of sealants Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers * Surface preparation prior to placing composite restorations » Effective plaque and stain removal for orthodontic patients * Cleaning prior to bonding ortho brackets * Cleaning implant fixtures prior to loading » Stain removal for shade determination * Plaque removal prior to fluoride treatment * Plaque and stain removal prior to whitening procedures combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Source page: https://510kreport.com/device/K231391
Methodology: https://510kreport.com/methodology