# K151262: Hyflex Heavy, Hyflex Mono, Hyflex Light

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 21, 2015 after 131 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: 5 generations back to K943574 (1994). 9 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 21 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 4.

## Most influential descendants
- K170736: HySil Impression Materials (2017), 10 descendants of its own
- 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

## Indications for use
Hyflex Heavy and Mono are 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. Hyflex Mono is to be used as a medium-bodied tray or syringeable impression material for; - Taking impression 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. Hyflex Light is to be used as syringeable impression materials for; - Two step putty-wash impression technique. - One step putty-wash impression technique. - One step impression technique using a foil(plastic putty spacer). - Reline impressions. - Fabricating full or partial dentures.

Source page: https://510kreport.com/device/K151262
Methodology: https://510kreport.com/methodology