# K181236: HySil Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 13, 2018 after 126 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.
1 later device descends from it; 1 cites it directly.
0 of 16 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
- K210041: HySil Plus Impression Materials (2021), 0 descendants of its own

## Indications for use
HySil Heavy 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 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 Bite is used for impression as below. - Taking occlusal surfaces - Confirming occlusal surfaces - Recording after putting the articulator

Source page: https://510kreport.com/device/K181236
Methodology: https://510kreport.com/methodology