# K233596: VarseoSmile TriniQ

- Pathway: 510(k) (Traditional)
- Applicant: Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
- Decided: Nov 9, 2023 after 1 day
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K042819 (2004). 17 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K213343: Saremco Print CROWNTEC, Saremco Dental AG (2022) Summary page 4.

## Most influential descendants
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (2025), 1 descendant of its own
- K261356: Dura-Crown (2026), 0 descendants of its own
- K250497: Additive Manufacturing (Light Curing) Crown Bridge Resin (2025), 0 descendants of its own

## Indications for use
VarseoSmile TriniQ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

Source page: https://510kreport.com/device/K233596
Methodology: https://510kreport.com/methodology