# K110379: Air-N-GO

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Dec 8, 2011 after 301 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). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092289: Ems Air-Flow Handy Perio, E.M.S Electro Medical Systems S.A (2009) Summary page 1.
- K022119: Ems Air-Flow Handy 2 Dental Handpiece, Electro Medical Systems SA (2002) Summary page 1.
- K082791: Ems Air-Flow Master, E.M.S Electro Medical Systems S.A (2009) Summary page 1.

## Most influential descendants
- K140684: Clinpro Prophy Powder (2014), 1 descendant of its own
- K151748: Clean & More (2016), 0 descendants of its own
- K130862: Cavitron Prophy-Jet Air Polishing Prophylaxis System (2013), 0 descendants of its own

## Indications for use
The AIR-N-GO by SATELEC in supra-gingival configuration is intended for use in the polishing and cleaning of teeth by the projection of a mixture of dental powder, air, water on teeth surfaces. The device can remove soft deposits and areas of discoloration and can be used to prepare teeth for conventional 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 be used to d.0grease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. The AIR-N-GO by SATELEC in sub-gingival configuration (with PERIO kit) is intended for patients suffering from periodontitis and peri-implantitis and it is indicated for the non-surgical removal of sub-gingival plaque in pockets up to 5 mm after an initial periodontal treatment.

Source page: https://510kreport.com/device/K110379
Methodology: https://510kreport.com/methodology