# K031467: Glasionomer FX-II

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Jul 17, 2003 after 70 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940122 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961448: Fuji IX GP, GC America, Inc. (1996) Summary page 1.
- K940122: HY Bond, Glasionomer CX, Shofu Dental Corp. (1994) Summary page 1.

## Indications for use
Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations Glasionomer FX-II is intended for use as a final restorative for deciduous teeth; a geriatric restorative for Class I, 11, Ill and V cavities and cervical erosions; a final restorative for Class I and 11 of adult dentition in non-load bearing situations; an intermediate restorative for heavy stress cavities; a core build up; and for pit and fissure fillings.

Source page: https://510kreport.com/device/K031467
Methodology: https://510kreport.com/methodology