# K141610: Futurabond M+

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Aug 1, 2014 after 46 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 3, 2016 · Class II · Z-0955-2017: Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.

## Indications for use
Futurabond M+ is intended for use as: [A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / OrmocerR materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or OmocerR restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups. [F2] Adhesive for indirect restorations using dual-curing or self-curing luting composites. [G] Luting of root posts with dual-curing or self-curing luting composites. [H] Primer for surface preparation of adhesively luted indirect restoration materials and root posts.

Source page: https://510kreport.com/device/K141610
Methodology: https://510kreport.com/methodology