# K233954: Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

- Pathway: 510(k) (Traditional)
- Applicant: B&E Korea Co., Ltd.
- Decided: Feb 13, 2024 after 60 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). 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)
- K152615: Vonflex S, Vericom Co., Ltd. (2016) Summary page 5.
- K170736: HySil Impression Materials, Osstem Implant Co., Ltd. (2017) Summary page 5.

## Indications for use
Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions Chemi-SiL Bite-Blu - Impression of the occlusal surface

Source page: https://510kreport.com/device/K233954
Methodology: https://510kreport.com/methodology