# K110403: Prolink Adhesives (Prolink, Prolink SE)

- Pathway: 510(k) (Traditional)
- Applicant: Silmet, Ltd.
- Decided: Sep 8, 2011 after 209 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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 K942493 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962785: 3M Dent System, 3M Company (1996) Summary page 1.
- K083652: Ibond Total Etch, Heraeus Kulzer,GmbH (2009) Summary page 1.
- K041471: G-BOND, GC America, Inc. (2004) Summary page 1.
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (2023), 0 descendants of its own

## Indications for use
Direct Composite or Compomner restorations Adhesive cementation Composite repair Bonding of composites to tooth structure Core Build up Adhesive cementation of crown & bridges, including inlays and onlays

Source page: https://510kreport.com/device/K110403
Methodology: https://510kreport.com/methodology