# K090817: Ionolux

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Jul 23, 2009 after 120 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
Longest line of descent: 1 generation back to K961584 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961584: Fuji II LC (Improved), GC America, Inc. (1996) Summary page 1.

## Recalls of this device
- Jan 25, 2024 · Class II · Z-1143-2024: 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
Ionolux is intended for the following applications: - 1. Restorations class III and V, especially cervical fillings and root caries - 2. Fillings on deciduous teeth - 3. Small class I fillings - 4. Temporary fillings - 5. Core build-up - 6. Lining

Source page: https://510kreport.com/device/K090817
Methodology: https://510kreport.com/methodology