# K971372: Variolink II

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: May 29, 1997 after 45 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
No predicates in its family tree.
7 later devices descend from it; 4 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K142389: Variolink Esthetic (2014), 3 descendants of its own
- 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
- K141503: Denali 501CEMENT (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K971372
Methodology: https://510kreport.com/methodology