# K082753: Futurabond M/Futurabond M Single Dose

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Nov 24, 2008 after 66 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
Longest line of descent: 2 generations back to K042913 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 1.
- K051796: Clearfil Tri-S Bond Single Dose, Kuraray Medical Kurashiki Plant (2005) Summary page 1.

## Indications for use
Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes. Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.

Source page: https://510kreport.com/device/K082753
Methodology: https://510kreport.com/methodology