# K160345: Glass Ionomer Cement

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: Mar 3, 2017 after 389 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 K980682 (1998). 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)
- K980682: Fuji II, GC America, Inc. (1998) Summary page 4.

## Indications for use
Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications: (1) Restoration of primary teeth. (2) Restorations of Class III, V and limited Class I cavities. (3) Base linings under composite and amalgam. (4) Core build-up.

Source page: https://510kreport.com/device/K160345
Methodology: https://510kreport.com/methodology