# K992645: Sinfony

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Sep 22, 1999 after 47 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: 3 generations back to K902115 (1990). 13 ancestors in all.
59 later devices descend from it; 5 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973513: Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic Modifiers, Sinfony Opaquer, Espe GmbH & Co. Kg. (1997) Summary page 1.
- K962878: Targis System, Ivoclar North America, Inc. (1996) Summary page 1.
- K964578: Fibrekor, Jeneric/Pentron, Inc. (1996) Summary page 1.
- K962440: Pertac II/Pertac II Aplitip, Espe GmbH & Co. Kg. (1996) Summary page 1.
- K950203: Protemp (R) Garant, Espe GmbH & Co. Kg. (1995) Summary page 1.
- K990763: Vitron M, Espe Dental AG (1999) Summary page 2.
- K991220: Vitron H, Espe Dental AG (1999) Summary page 2.

## Most influential descendants
- 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
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own

## Indications for use
Full veneering of crowns and bridges Complete crowns Inlays/onlays Fiber reinforced crowns and bridges Direct bonded bridges Telescopic and conical crowns Attachments and implant works Veneers Long term temporary restorations and their characterization Customization of acrylic and ceramic artificial teeth Extraoral repairs

Source page: https://510kreport.com/device/K992645
Methodology: https://510kreport.com/methodology