# K994077: Aroma Fine (Normal and Fast Set)

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jan 27, 2000 after 56 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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.

## Indications for use
Aroma Fine is a dust free alginate impression material used for taking impressions to obtain a detailed reproductlon of the oral anotomy.

Source page: https://510kreport.com/device/K994077
Methodology: https://510kreport.com/methodology