# K203824: VPS Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Hygedent, Inc.
- Decided: Apr 19, 2021 after 111 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: 8 generations back to K943574 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192941: HySil Super Fast Impression Materials, Osstem Implant Co., Ltd. (2020) Summary page 4.

## Indications for use
VPS Inpression Material(Light Body) is to be used as syringeable impression materials for: -Two-step putty-wash impression technique; -One-step putty-wash impression technique; - Two-step impression technique using dual viscosities; - Reline impressions; -Fabricating full or partial dentures;

Source page: https://510kreport.com/device/K203824
Methodology: https://510kreport.com/methodology