# K201668: VarseoSmile Crown plus

- Pathway: 510(k) (Traditional)
- Applicant: Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
- Decided: Jun 23, 2020 after 4 days
- 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: 6 generations back to K042819 (2004). 13 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162537: CAD/CAMouflage Milling Block, Prismatik Dentalcraft, Inc. (2016) Summary page 4.

## Most influential descendants
- K202846: Tera Harz (2021), 13 descendants of its own
- K210977: E-Dent 1000 (2021), 7 descendants of its own
- K213343: Saremco Print CROWNTEC (2022), 6 descendants of its own
- K222623: Digital Crown (2022), 4 descendants of its own
- K233596: VarseoSmile TriniQ (2023), 3 descendants of its own

## Indications for use
VarseoSmile Crown P is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown P material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.

Source page: https://510kreport.com/device/K201668
Methodology: https://510kreport.com/methodology