# K152691: EDS Universal Cement

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Feb 25, 2016 after 157 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: 10 generations back to K931812 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100908: Unicem HM, 3M Espe AG Dental Products (2010) Summary page 4.

## Indications for use
- Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws. - Final cementation of ceramic, composite, or metal restorations on implant abutments. - Permament cementation of ceramic or composite veneers.

Source page: https://510kreport.com/device/K152691
Methodology: https://510kreport.com/methodology