# K160774: IonoStar Plus

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Aug 3, 2016 after 135 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jan 25, 2024 · Class II · Z-1142-2024: Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When 

## Indications for use
fonoStar Plus is intended for use as: - Restorations of non occlusion-bearing class | cavities - Semi-permanent restorations of class | and |l cavities - Restorations of cervical lesions, class V cavities, root caries - Restorations of class lli cavities - Restoration of deciduous teeth - Basel/liner - Core build-up - Temporary restorations - Extended fissure sealing

Source page: https://510kreport.com/device/K160774
Methodology: https://510kreport.com/methodology