# K980963: Honigum Automix Impression Material (Foil Bags) and Honigum Quick Impression Material (Cartridges)

- Pathway: 510(k) (Traditional)
- Applicant: Foremost Dental Mfg., Inc.
- Decided: May 11, 1998 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
Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.

Source page: https://510kreport.com/device/K980963
Methodology: https://510kreport.com/methodology