# K161851: Glass Ionomer Cement (Luting)

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: Oct 31, 2016 after 117 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 K980695 (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)
- K980695: FUJI I, GC America, Inc. (1998) Summary page 4.

## Indications for use
Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications: (1) Cementation of metal-based inlays, onlays, crowns and bridges; (2) Cementation of high strength (zirconia based) all ceramic crowns and bridges; (3) Cementation of posts and screws made of metal or high-strength ceramic; (4) Cementation of orthodontic bands; (5) Restoration of caries in unstressed area (Luting II only).

Source page: https://510kreport.com/device/K161851
Methodology: https://510kreport.com/methodology