# K210041: HySil Plus Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Mar 18, 2021 after 70 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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.
- K181236: HySil Impression Materials, Osstem Implant Co., Ltd. (2018) Summary page 4.

## Indications for use
HySil Heavy Plus 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 Plus 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 Plus 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 HySil Heavy Plus Auto 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

Source page: https://510kreport.com/device/K210041
Methodology: https://510kreport.com/methodology