# K994268: Arabesk Top

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Feb 3, 2000 after 48 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 K910263 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964285: Tetric Ceram, Ivoclar North America, Inc. (1997) Summary page 2.
- K910263: Charisma, Kulzer, Inc. (1991) Summary page 2.
- K954929: Charisma Single Dose, Heraeus Kulzer, Inc. (1995) Summary page 2.

## Most influential descendants
- K063604: Twinky Star NF (2007), 0 descendants of its own

## Indications for use
Arabesk® Top is a light-curing, radiopaque ceramic microhybrid composite filling material for both anterior and posterior applications, as well as for inlay techniques. Arabesk® Top is intended for use in restoring: Class I-V fillings Reconstruction of traumatically affected anteriors Facetting of discolored anteriors Color and/or shape corrections to improve asthetic appearance Locking or splinting of loose anteriors Extended fissure sealaing for molars and premolars Repairing veneers Core build-up under crowns Especially suited for composite inlays

Source page: https://510kreport.com/device/K994268
Methodology: https://510kreport.com/methodology
