# K192941: HySil Super Fast Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Jan 30, 2020 after 104 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: 7 generations back to K943574 (1994). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170736: HySil Impression Materials, Osstem Implant Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K203824: VPS Impression Material (2021), 0 descendants of its own
- K210041: HySil Plus Impression Materials (2021), 0 descendants of its own

## Indications for use
HySil Heavy Super Fast is to be used as heavy-bodied materials for: - One-step impression technique (simultaneous technique) using single or dual viscosities - Two-step impression technique using dual viscosities - Functional impressions HySil Mono Super Fast is to be used as a medium-bodied tray or syringeable impression material for: - Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) - Functional impressions - Fabricating crown and bridgework or inlays - Fabricating full or partial dentures - Reline impressions - Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques - Transferring root posts when fabricating posts and cores indirectly HySil Light Super Fast 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/K192941
Methodology: https://510kreport.com/methodology