# K193553: VarseoSmile Temp

- Pathway: 510(k) (Traditional)
- Applicant: Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
- Decided: May 18, 2020 after 150 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K233273: C&B Ceramic; C&B Permanent; C&B Interim (2024), 0 descendants of its own
- K240538: Premium Teeth Resin (2024), 0 descendants of its own

## Indications for use
VarseoSmile Temp resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral light-curing equipment.

Source page: https://510kreport.com/device/K193553
Methodology: https://510kreport.com/methodology