# K142389: Variolink Esthetic

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, AG
- Decided: Nov 25, 2014 after 90 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971372 (1997). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971372: Variolink II, Ivoclar North America, Inc. (1997) Summary page 4.

## Most influential descendants
- K242572: TopCEM-Try in Veneer Try-in Gel (2024), 0 descendants of its own
- K241204: TopCEM-Veneer Light Cure Veneer Cement (2024), 0 descendants of its own
- K191389: Allcem Veneer APS (2020), 0 descendants of its own

## Indications for use
Variolink Esthetic LC: – Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers) - Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT). Variolink Esthetic DC: – Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays,partial crowns, crowns, bridges). – Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured. Variolink Esthetic Try-In To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.

Source page: https://510kreport.com/device/K142389
Methodology: https://510kreport.com/methodology