# K974488: Airprep System - Model 9001

- Pathway: 510(k) (Traditional)
- Applicant: Asi Medical, Inc.
- Decided: May 26, 1998 after 181 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) Micadent: named in the summary without a submission number

## Indications for use
The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations. The AirPrep System is substantially similar in design and function as the Micadent manufactured by Hampton Research and marketed by Medidenta International. The Micadent will be supplied to ASI as a completed product. The AirPrep will be only marketed for the same purposes as the Micadent.

Source page: https://510kreport.com/device/K974488
Methodology: https://510kreport.com/methodology