# K973679: Aeroetcher

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Mar 10, 1998 after 165 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. The FDA summary names its predicate without a number.
- (no number) Microetcher: named in the summary without a submission number
- (no number) Accu-Prep: named in the summary without a submission number

## Indications for use
An air-driven device that permits the user to abrade surfaces of dental materials, either intra- or extra-orally, in order to enhance the bond strength of resinous materials applied to the air-abraded surfaces and polymerized thereon.

Source page: https://510kreport.com/device/K973679
Methodology: https://510kreport.com/methodology