# K123773: X-Tra Base

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Dec 21, 2012 after 14 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K141994: Bulk Fill Flowable Composite (2014), 0 descendants of its own

## Indications for use
x-tra base: * Base in class I and II cavities * Cavity lining under direct restorative materials in class I and II cavities * Class III and V restorations * Conservative Class I restorations * Small Class IV repairs * Tunnel Preparations * Filling of defects and undercuts in crown, inlay and onlay preparations * Blockouts; * Repair of small enamel defects * Covering incisal edge stains * Pit and fissure sealant * Cementing porcelain veneers. crowns, inlays and onlays * Intraoral porcelain repair * Amalgam margin repair * Improving margins of acrylic temporaries * Provisional occlusal changes * Refacing acrylic temporaries * Margin correction/adjustment of composite crowns for Indirect laboratory use

Source page: https://510kreport.com/device/K123773
Methodology: https://510kreport.com/methodology