# K030292: Groman Prepmaster

- Pathway: 510(k) (Traditional)
- Applicant: Groman, Inc.
- Decided: Apr 15, 2003 after 77 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
- K100833: Syle Smartip (2010), 0 descendants of its own

## Indications for use
Cutting and Preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite restorations. For roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. Indications for use are identical to Microetcher AP/PrepStarTM by Danville Engineering Inc. For Use by Dentists Only.

Source page: https://510kreport.com/device/K030292
Methodology: https://510kreport.com/methodology