# K062292: Unicem

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Oct 25, 2006 after 79 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
Longest line of descent: 1 generation back to K002364 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002364: Protemp H, Espe Dental AG (2000) Summary page 2.

## Most influential descendants
- K093338: Self Adhesive Composite Luting Cement (2010), 2 descendants of its own
- K101787: Duolink II (2010), 1 descendant of its own
- K250156: Choice 2 DC (2025), 0 descendants of its own

## Indications for use
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneer and orthodontic strips.

Source page: https://510kreport.com/device/K062292
Methodology: https://510kreport.com/methodology