# K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Oct 20, 2019 after 268 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900709 (1990). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110173: Ems Air-Flow Master Piezon, E.M.S Electro Medical Systems S.A (2011) Summary page 7.

## Most influential descendants
- K231391: Combi Touch (2023), 1 descendant of its own
- K260773: Varios Combi Pro2 (2026), 0 descendants of its own
- K253254: GBT Machine Airflow Prophylaxis Master (2026), 0 descendants of its own
- K251425: turbodent touch (2025), 0 descendants of its own

## Recalls of this device
- Mar 13, 2024 · Class II · Z-1686-2024: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the press
- Mar 13, 2024 · Class II · Z-1687-2024: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the press
- Mar 13, 2024 · Class II · Z-1688-2024: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the press

## Indications for use
The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications: • Removing supra and subgingival calculus deposits and stains from teeth • 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 root canals • Cavity preparation • Cementing inlays and onlays • Retrograde preparation of root canals The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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. The AIRFLOW Prophylaxis Master can be used for the following cleaning 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 fixture prior to loading • stain removal for shade determination • plaque removal prior to fluoride treatment • plaque and stain removal prior to whitening procedure The AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. The AIRFLOW One is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental 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. The AIRFLOW One can be used for the following cleaning 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 fixture prior to loading • stain removal for shade determination • plaque removal prior to fluoride treatment • plaque and stain removal prior to whitening procedure The AIRFLOW One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One 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/K190124
Methodology: https://510kreport.com/methodology