# K965083: Super-Dent Alginate,Normal Set, Fast Set,Super Deluxe Dustless Alginate, Normal Set, Deluxe Dutless Alginate, Fast Set

- Pathway: 510(k) (Traditional)
- Applicant: S.S. White Mfg., Ltd.
- Decided: Apr 4, 1997 after 106 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
Longest line of descent: 1 generation back to K883842 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883842: Dental Alginate Impression Material W/Anti. Addi., Dentsply Intl. (1989) Summary page 1.

## Indications for use
These materials are intended for use in taking impressions of oral tissues for preparation of orthodontic prostheses and to create study models required in designing and fitting of such devices.

Source page: https://510kreport.com/device/K965083
Methodology: https://510kreport.com/methodology