# K974140: Adhesive Hybrid Ionomer Cement

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jan 5, 1998 after 63 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 K940914 (1994). 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)
- K940914: New Luting Cement Material (NLC), Dentsply Intl. (1994) Summary page 1.

## Indications for use
ADHESIVE HYBRID IONOMER CEMENT is used for: Adhesive cementation of all metal crowns and bridges including precious, semi-precious and non-precious metals Adhesive cementation of conventional porcelain fused to metal crowns and bridges with metal margins Adhesive cementation of gold inlays and onlays Adhesive cementation of prefabricated and cast posts. Adhesive cementation of porcelain/ceramic/composite substrate crowns Adhesive cementation of porcelain jacket crowns (including foil or electroplated lined crowns) Adhesive cementation of porcelain fused to metal (PFM) crowns with porcelain margins Adhesive liner for bonding freshly placed direct amalgam restorations

Source page: https://510kreport.com/device/K974140
Methodology: https://510kreport.com/methodology