# K171189: AIR-FLOW PLUS Prophylaxis powder

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Sep 11, 2017 after 140 days
- Product code: EJR (Agent, Polishing, Abrasive, Oral Cavity)
- Device class: 1
- Regulation: 21 CFR 872.6030
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082791: Ems Air-Flow Master, E.M.S Electro Medical Systems S.A (2009) Summary page 4.
- K110173: Ems Air-Flow Master Piezon, E.M.S Electro Medical Systems S.A (2011) Summary page 4.

## Indications for use
The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

Source page: https://510kreport.com/device/K171189
Methodology: https://510kreport.com/methodology