# K033215: Prepair

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, Inc.
- Decided: Jan 9, 2004 after 98 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: 1 generation back to K970589 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970589: Microetcher AP, Danville Engineering, Inc. (1997) Summary page 1.
- K974655: Preptech (TM) 200 Cavity Preparation System, Prep Technology Corp. (1998) Summary page 1.
- K981564: Air Techniques' Airdent II, Air Techniques, Inc. (1998) Summary page 1.
- K002708: Kavo Corund Handpiece 2013, Kavo America (2000) Summary page 1.

## Indications for use
The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.

Source page: https://510kreport.com/device/K033215
Methodology: https://510kreport.com/methodology