# K170896: Admira Fusion x-base

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Jun 29, 2017 after 94 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Base inclass | and Il cavities Cavity lining under direct restorative materials in class | and Il cavities Small, non occlusal stress-bearing class | restorations according to minimally invasive filling therapy Class lll and V restorations Extended fissure sealing Undercut blockout Repair of small enamel defects Repair of small defects in aesthetic indirect restorations Repair of temporary C&B-materials Core build-up

Source page: https://510kreport.com/device/K170896
Methodology: https://510kreport.com/methodology