# K973513: Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic Modifiers, Sinfony Opaquer

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Dec 22, 1997 after 96 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: 1 generation back to K833757 (1984). 2 ancestors in all.
60 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833757: Visio-Gem, Espe GmbH (Us) (1984) Summary page 1.
- K905604: Visio-Gem Art-System, Espe GmbH (Us) (1991) Summary page 1.

## Most influential descendants
- 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
- K112118: Dreambond (2011), 8 descendants of its own

## Indications for use
Full and partial coverage of: fixed crown and bridgework telescopic and conical crowns precision attachments implant superstructures adhesive bridgework laminate veneers individualizing denture teeth individualizing long-term temporary restorations

Source page: https://510kreport.com/device/K973513
Methodology: https://510kreport.com/methodology