# K130862: Cavitron Prophy-Jet Air Polishing Prophylaxis System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Jul 23, 2013 after 117 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900709 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970342: Cavitron Jet with SPS System, Dentsply Intl. (1997) Summary page 1.
- K052334: Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131, Dentsply Intl. (2005) Summary page 2.
- K110173: Ems Air-Flow Master Piezon, E.M.S Electro Medical Systems S.A (2011) Summary page 1.
- K110379: Air-N-GO, Satelec (2011) Summary page 3.

## Indications for use
The Cavitron Prophy-Jet Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for: Stain removal, Prophylaxis of orthodontic patients, Preparing tooth surface prior to bonding and sealant procedures, and Implant debridement

Source page: https://510kreport.com/device/K130862
Methodology: https://510kreport.com/methodology