# K253254: GBT Machine Airflow Prophylaxis Master

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Jan 28, 2026 after 121 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.
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 GBT Machine AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The GBT Machine 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 The GBT Machine 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 GBT Machine 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 GBT Machine AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The GBT Machine AIRFLOW Prophylaxis Master 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/K253254
Methodology: https://510kreport.com/methodology