# K110508: Suglue-10

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG
- Decided: Jun 3, 2011 after 101 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). 32 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100756: MALTA, 3M Espe AG Dental Products (2010) Summary page 1.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 1.
- K062519: NEXUS 3, Kerr Corporation (2006) Summary page 1.

## Most influential descendants
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (2016), 5 descendants of its own
- K200798: G-Cem One (2020), 3 descendants of its own
- K254109: G-Cem Universal (2026), 0 descendants of its own
- K254063: iCEM Universal Plus (2025), 0 descendants of its own
- K251946: G aenial Universal Injectable II (2025), 0 descendants of its own

## Indications for use
Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementing of posts and screws Final cementation of all-ceramic, or composite veneers Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Source page: https://510kreport.com/device/K110508
Methodology: https://510kreport.com/methodology