# K100756: MALTA

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Jun 2, 2010 after 77 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: 9 generations back to K931812 (1993). 30 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020256: Unicem, 3M Espe AG Dental Products (2002) Summary page 1.
- K094007: Unicem, 3M Espe AG Dental Products (2010). Cleared while this submission was under review Summary page 1.
- K032455: Panavia F 2.0, Kuraray Medical, Inc. (2003) Summary page 1.
- K073209: Maxcem 2, Kerr Corporation (2008) Summary page 1.

## Most influential descendants
- K110508: Suglue-10 (2011), 8 descendants of its own
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (2016), 5 descendants of its own
- K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S (2012), 5 descendants of its own
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS) (2015), 4 descendants of its own
- K200798: G-Cem One (2020), 3 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, composite, or metal restorations on implant abutments.

Source page: https://510kreport.com/device/K100756
Methodology: https://510kreport.com/methodology