# K905604: Visio-Gem Art-System

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH (Us)
- Decided: Mar 29, 1991 after 108 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
No predicates in its family tree.
61 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973513: Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic Modifiers, Sinfony Opaquer (1997), 60 descendants of its own
- K992645: Sinfony (1999), 59 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K042929: Estenia C&B (2004), 12 descendants of its own

Source page: https://510kreport.com/device/K905604
Methodology: https://510kreport.com/methodology