# K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

- Pathway: 510(k) (Traditional)
- Applicant: Genoss Co., Ltd.
- Decided: Dec 15, 2022 after 353 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
- 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
Impression of inlay, onlay crown, and bridge preparation - Crown, bridge impression - Inlay and onlay impression - Functional impression - Denture impression - Study model impression

Source page: https://510kreport.com/device/K214086
Methodology: https://510kreport.com/methodology