# K170736: HySil Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Jun 7, 2017 after 89 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: 6 generations back to K943574 (1994). 13 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light, Osstem Germany GmbH (2014) Summary page 5.
- K151262: Hyflex Heavy, Hyflex Mono, Hyflex Light, Osstem Implant Co., Ltd. (2015) Summary page 5.
- K152766: CharmFlex, Dentkist, Inc. (2016) Summary page 5.

## Most influential descendants
- K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (2022), 2 descendants of its own
- K192941: HySil Super Fast Impression Materials (2020), 2 descendants of its own
- K181236: HySil Impression Materials (2018), 1 descendant of its own
- K254152: Dia-X Sil Light Body (2026), 0 descendants of its own
- K254142: Dia-X Sil Heavy Body (2026), 0 descendants of its own

## Indications for use
HySil Putty is to be used as preliminary materials for: ˍ Two-step Putty-wash impression technique ˍ One-step Putty-wash impression technique HySil Heavy is to be used as heavy-bodied materials for: ˍ One-step impression technique (simultaneous technique) using single or dual viscosities ˍ Two-step impression technique using dual viscosities ˍ Functional impressions HySil Mono is to be used as a medium-bodied tray or syringeable impression material for: ˍ Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) ˍ Functional impressions ˍ Fabricating crown and bridgework or inlays ˍ Fabricating full or partial dentures ˍ Reline impressions ˍ Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques ˍ Transferring root posts when fabricating posts and cores indirectly HySil Light is to be used as syringeable impression materials for: ˍ Two-step putty-wash impression technique ˍ One-step putty-wash impression technique ˍ Two-step impression technique using dual viscosities ˍ Reline impressions ˍ Fabricating full or partial dentures HySil Extra Light is to be used as syringeable impression materials for: ˍ Two-step putty-wash impression technique ˍ One-step putty-wash impression technique ˍ Two-step impression technique using dual viscosities ˍ Reline impressions ˍ Fabricating full or partial dentures HySil Bite is used for impression as below. ˍ Taking occlusal surfaces ˍ Confirming occlusal surfaces ˍ Recording after putting the articulator

Source page: https://510kreport.com/device/K170736
Methodology: https://510kreport.com/methodology