# K254142: Dia-X Sil Heavy Body

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Sep 16, 2026 after 268 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty, Genoss Co., Ltd. (2022) Summary page 5.
- K223892: DentMix VPS Impression Material, Innovative Product Brands, Inc. (2023) Summary page 5.

## Indications for use
- Crown and bridge impressions - Inlay and onlay impressions - Functional impressions - Implant impressions - Denture and partial denture impressions

Source page: https://510kreport.com/device/K254142
Methodology: https://510kreport.com/methodology