# K254112: Dia-X Sil Bite

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Mar 19, 2026 after 90 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: 1 generation back to K882690 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882690: Imprint Vinyl Polysiloxane Impression Material, 3M Company (1988) Summary page 5.

## Indications for use
- Indicated for bite registration in prosthodontics, orthodontics, and implantology. - Used for recording the occlusal relationship to aid in the fabrication of crowns, bridges, dentures, and orthodontic appliances. - Suitable of occlusal analysis and adjustment in clinical dental procedures.

Source page: https://510kreport.com/device/K254112
Methodology: https://510kreport.com/methodology