# K981564: Air Techniques' Airdent II

- Pathway: 510(k) (Traditional)
- Applicant: Air Techniques, Inc.
- Decided: Sep 24, 1998 after 146 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K033215: Prepair (2004), 0 descendants of its own

## Indications for use
The AIRDENT II AIR ABRASION SYSTEM is designed for use by Dentists and sold through authorized Air Techniques' Dealers for the following purposes: 1-Cavity preparations for composite restorations and small amalgam fillings and preparations for aesthetic composite procedures. 2-Composite restoration removal. 3-Partial composite restoration removal and repair or rebonding at failure sites. 4-Preparation for pit and-fissure sealants. 5-Etching of tooth structure and porcelain for bonding. Acid etching materials' should be used in conjunction with the AIRDENT II in bonding procedures.

Source page: https://510kreport.com/device/K981564
Methodology: https://510kreport.com/methodology