# K132480: Air-Flow Handy 3.0 Perio

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Feb 24, 2014 after 200 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: 3 generations back to K900709 (1990). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 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 1.

## Most influential descendants
- K151912: AIR-FLOW handy 3.0 PLUS (2016), 2 descendants of its own
- K171174: PERIO-FLOW nozzle (2017), 1 descendant of its own
- K241880: Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (2024), 0 descendants of its own
- K221548: Dental Air Polishing Handpiece (2022), 0 descendants of its own

## Indications for use
The AmR-FLOW handy 3.0 PERIO is intended far patients suffering from periodontal disease. The AmR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in packets up to 5 mm after initial periodontal treatment.

Source page: https://510kreport.com/device/K132480
Methodology: https://510kreport.com/methodology