# K991857: Airflow Handy

- Pathway: 510(k) (Traditional)
- Applicant: Electro Medical Systems, Inc.
- Decided: Oct 7, 1999 after 128 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: 1 generation back to K900709 (1990). 2 ancestors in all.
23 later devices descend from it; 1 cites 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)
- K900709: Air Flow Sii, Electro Medical Systems (Ems Sa) (1990) Summary page 2.
- K973876: Prophyflex 2, Model 2012, Kavo America (1997) Summary page 2.

## Most influential descendants
- K022119: Ems Air-Flow Handy 2 Dental Handpiece (2002), 22 descendants of its own
- 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

## Indications for use
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers. The device can also be used to clean the following: • implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching • crowns and bridges • fixed bands and brackets prior to placement on orthodontic appliances.

Source page: https://510kreport.com/device/K991857
Methodology: https://510kreport.com/methodology