# K042846: Systemp.Link

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Dec 20, 2004 after 66 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K160443: TempoCem Clear (2016), 0 descendants of its own

## Indications for use
For the temporary cementation of temporary inlays, onlays, partial crowns, crowns or bridges. The retention period should not last longer than 8 weeks.

Source page: https://510kreport.com/device/K042846
Methodology: https://510kreport.com/methodology