# K112869: Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400

- Pathway: 510(k) (Traditional)
- Applicant: Beyes Dental Canada, Inc.
- Decided: Dec 16, 2011 after 77 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: 4 generations back to K900709 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032395: Prophy-Mate, Nakanishi, Inc. (2003) Summary page 2.
- K092289: Ems Air-Flow Handy Perio, E.M.S Electro Medical Systems S.A (2009) Summary page 2.

## Indications for use
The EasyProphy Series Air Polish Devices are intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.

Source page: https://510kreport.com/device/K112869
Methodology: https://510kreport.com/methodology