# K032470: Multilink

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Nov 5, 2003 after 86 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K123397: Multilink Automix (2013), 5 descendants of its own
- K201790: Dual Cure Resin Cement (2020), 2 descendants of its own
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (2013), 1 descendant of its own
- K241204: TopCEM-Veneer Light Cure Veneer Cement (2024), 0 descendants of its own
- K233082: TopCEM Dual Cure Resin Cement (2023), 0 descendants of its own

## Indications for use
Multilink® is a self-curing and self-etching luting composite system for the adhesive luting of indirect restorations made of metal, metal-ceramic, all-ceramic and composite. It is contraindicated if the patient has allergies to any ingredient; and no direct application on pulpa-near dentin or on the open pulp or irritations of the pulp may occur.

Source page: https://510kreport.com/device/K032470
Methodology: https://510kreport.com/methodology