# K993932: Solitaire 2

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Dec 22, 1999 after 34 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
Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. This product is designed for filling of the classes I, II, and V according to Black. It also can be used for splinting of teeth which are traumatically loose, restoration of primary teeth and reconstruction of stumps. It is available in the shades A1, A2, A3, A3.5, A4, B2, B3, B4, C3, and Incisal.

Source page: https://510kreport.com/device/K993932
Methodology: https://510kreport.com/methodology