# K192992: Suglue 3

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: Nov 5, 2019 after 11 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)
- K100756: MALTA, 3M Espe AG Dental Products (2010) Summary page 4.

## Indications for use
Use of Suglue 3 in Adhesive Mode with ADH 19 •Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges •Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops) Use of Suglue 3 in Adhesive Mode with ADH 19 or in Self-Adhesive Mode •Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges •Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws •Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Source page: https://510kreport.com/device/K192992
Methodology: https://510kreport.com/methodology