# K073284: Air-Flow Master Standard

- Pathway: 510(k) (Special)
- Applicant: (Ems Sa) Electro Medical Systems
- Decided: Dec 14, 2007 after 23 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). 1 ancestor in all.
25 later devices descend from it; 4 cite it directly.
0 of 27 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 1.

## Most influential descendants
- K082791: Ems Air-Flow Master (2009), 23 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
- K132480: Air-Flow Handy 3.0 Perio (2014), 4 descendants of its own

## Indications for use
The AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. The device can also be used for the following cleaning procedures: * plaque removal for placement of sealants * surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers * surface preparation prior to placing composite restorations * effective plaque and stain removal for orthodontic patients * cleaning prior to bonding ortho brackets * cleaning implant fixture prior to loading * stain removal for shade determination * plaque removal prior to fluoride treatment * plaque and stain removal prior to whitening procedure

Source page: https://510kreport.com/device/K073284
Methodology: https://510kreport.com/methodology