# K132923: Fusion Single Link

- Pathway: 510(k) (Traditional)
- Applicant: Angelus Industria DE Productos Odontologicos SA
- Decided: Jan 3, 2014 after 107 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 K942493 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962785: 3M Dent System, 3M Company (1996) Summary page 1.

## Indications for use
Bonding all classes of direct composite restorations as well as for indirect procedures Involving metal, porcelain, or composite crowns, Inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.

Source page: https://510kreport.com/device/K132923
Methodology: https://510kreport.com/methodology