# K222253: GlasIonomer FX ULTRA

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Sep 22, 2022 after 57 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
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
Restoration of deciduous teeth Non-load bearing Class I and Class II restorations in permanent teeth Restoration of Class III and Class V cavities and wedge shaped defects Core build-up

Source page: https://510kreport.com/device/K222253
Methodology: https://510kreport.com/methodology