# K252469: Magnabond SE; Magnabond Universal; Magnabond Universal Dca

- Pathway: 510(k) (Traditional)
- Applicant: Dmp Dental Industry S.A.
- Decided: Nov 6, 2025 after 92 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.
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.

## Indications for use
MAGNABOND SE * Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials * Bonding agent for core build-ups that are made with light-curing composites MAGNABOND UNIVERSAL * Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials * Bonding agent for core build-ups that are made of light-curing composites * Bonding agent for intraoral repair of composite or compomers restorations, porcelain fused to metal (PFM), ceramic veneers and all-ceramic restorations without an additional primer * Sealing of cavities prior to amalgam restorations * Sealing of cavities and core preparations prior to the temporary luting of indirect restorations *Treatment of hypersensitive teeth * Protective varnish for glass ionomer cement restorations COMBINED WITH MAGNABOND UNIVERSAL DCA: * Bonding agent for direct restorations of all classes of cavities using self or dual curing composites and core build-ups * Bonding agent for indirect restorations using self or dual curing luting composites/cements * Luting of root posts using self or dual curing luting composites/cements

Source page: https://510kreport.com/device/K252469
Methodology: https://510kreport.com/methodology