# K093338: Self Adhesive Composite Luting Cement

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Feb 12, 2010 after 112 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: 2 generations back to K002364 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062292: Unicem, 3M Espe Dental Products (2006) Summary page 1.
- K041474: Maxcem, Sybron Dental Specialties, Inc. (2004) Summary page 1.

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

## Indications for use
Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite lutinig cement. The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.

Source page: https://510kreport.com/device/K093338
Methodology: https://510kreport.com/methodology