# K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 6, 2016 after 240 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: 11 generations back to K931812 (1993). 60 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110508: Suglue-10, 3M Espe AG (2011) Summary page 7.
- K110302: Adhesive Exl-759, 3M Espe AG (2011) Summary page 7.
- K931309: Variolink, Ivoclar North America, Inc. (1993) Summary page 7.
- K001823: Linkmax, GC America, Inc. (2000) Summary page 7.

## Most influential descendants
- 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
- K242366: OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment (2025), 0 descendants of its own

## Indications for use
G-Cem LinkForce 1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges. 2. Cementation of metal, ceramic, fiber posts, and cast post and cores. 3. Cementation of all ceramic and composite veneers (up to 2 teeth) 4. Permanent cementation of crowns and bridges on implant abutments. GC DUAL CURE ACTIVATOR 1. Cementation of indirect restorations. 2. Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure. 3. Bonding of resin cements and core build-up materials and self-cure composites to tooth structure. TRY-IN PASTE To evaluate the shade and the fitting of the restoration prior to permanent cementation. MULTI PRIMER 1. Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures. 2. Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.

Source page: https://510kreport.com/device/K153231
Methodology: https://510kreport.com/methodology