# K022119: Ems Air-Flow Handy 2 Dental Handpiece

- Pathway: 510(k) (Special)
- Applicant: Electro Medical Systems SA
- Decided: Jul 25, 2002 after 24 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900709 (1990). 3 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991857: Airflow Handy, Electro Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K092289: Ems Air-Flow Handy Perio (2009), 18 descendants of its own
- K110173: Ems Air-Flow Master Piezon (2011), 13 descendants of its own
- K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (2019), 4 descendants of its own
- K132478: Air-Flow Handy 3.0 (2014), 3 descendants of its own
- K110379: Air-N-GO (2011), 3 descendants of its own

## Indications for use
The EMS AIR-FLOW@handy 2 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

Source page: https://510kreport.com/device/K022119
Methodology: https://510kreport.com/methodology