# K123397: Multilink Automix

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Jan 31, 2013 after 87 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032470 (2003). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032470: Multilink, Ivoclar Vivadent, Inc. (2003) Summary page 1.

## Most influential descendants
- K201790: Dual Cure Resin Cement (2020), 2 descendants 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
- K191527: Visalys CemCore, Visalys Cem Core Try In Paste (2019), 0 descendants of its own
- K162677: L- OVC (2016), 0 descendants of its own

## Indications for use
Multilink Automix Is used for the permanent cementation of Indirect restorations where a strong bond is desired: Inlays, onlays, crowns, bridges and root posts made of: Metal and metal ceramics All-ceramics, In particular opaque zirconium oxide ceramics Composites and fibre-reinforced composites

Source page: https://510kreport.com/device/K123397
Methodology: https://510kreport.com/methodology