# K020256: Unicem

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Mar 25, 2002 after 60 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: 3 generations back to K900510 (1990). 8 ancestors in all.
63 later devices descend from it; 8 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974458: Compolute Aplicap, Espe Dental-Medizin GmbH & Co.Kg. (1998) Summary page 1.
- K897188: Ketac-Cem Maxicap, Espe GmbH (Us) (1990) Summary page 1.
- K010781: 3M Espe Haur, 3M Company (2001) Summary page 1.
- K002364: Protemp H, Espe Dental AG (2000) Summary page 1.
- K873882: Alkaliner, Espe GmbH (Us) (1988) Summary page 1.

## Most influential descendants
- K043043: Hermes Bond 2 (2005), 37 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K100756: MALTA (2010), 19 descendants of its own
- K112118: Dreambond (2011), 8 descendants of its own

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

Source page: https://510kreport.com/device/K020256
Methodology: https://510kreport.com/methodology