# K003426: Alginate Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Rite-Dent Manufacturing Corp.
- Decided: Jan 23, 2001 after 81 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 1 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 21, 2005 · Not classified · Z-0128-06: At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on

Source page: https://510kreport.com/device/K003426
Methodology: https://510kreport.com/methodology