# K033675: Prosmile Air Polisher and Prophylaxis Powder

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Jan 15, 2004 after 52 days
- Product code: KOJ (Airbrush)
- Device class: 2
- Regulation: 21 CFR 872.6080
- 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022119: Ems Air-Flow Handy 2 Dental Handpiece, Electro Medical Systems SA (2002) Summary page 1.

## Most influential descendants
- K042872: Rondoflex Plus 360 (2004), 0 descendants of its own

## Indications for use
The ProSmile Air Polisher is intended for removing deposits, plaque, and staining on all visible tooth surfaces as well as in fissures and interdental areas. The ProSmile is also intended for the following prophylactic applications: * cleaning teeth prior to sealing * cleaning teeth prior to fluoridation * cleaning teeth prior to bleaching * cleaning teeth prior to using bonding materials

Source page: https://510kreport.com/device/K033675
Methodology: https://510kreport.com/methodology