# K130486: Futurabond  Universal

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Jun 20, 2013 after 115 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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; 1 cites 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
- K171226: Tokuyama Universal Bond (2017), 1 descendant of its own
- K203760: Tokuyama Universal Bond II (2021), 0 descendants of its own

## Indications for use
Futurabond Universal is intended for use as: Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base Adhesive for core build-ups made of light-curing composite materials Adhesive for indirect restorations with light-curing luting composites Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer Treatment of hypersensitive tooth necks Protective vamish for glass ionomer cement restorations Sealing of cavities prior to amalgam restorations Sealing of cavities and core preparations pnor to the temporary luting of indirect restorations Adhesive for direct self-curing or dual-curing .composite restorations of all classes of cavities and for core build-ups Adhesive for indirect restorations using dual-curing or self-curing luting composites Luting of root posts with dual-curing or self-curing luting composites

Source page: https://510kreport.com/device/K130486
Methodology: https://510kreport.com/methodology