# K101493: Advanced Glass Ionomer (K-130) Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Aug 19, 2010 after 79 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: 2 generations back to K843566 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960954: Ketac-Molar Aplicap, Espe GmbH & Co. Kg. (1996) Summary page 1.

## Indications for use
Advanced Glass Lonorner (K-13O) Restorative Material is indicated for semi-permanent restorations of class I and II cavities in posterior teeth; Restoration of deciduous teeth; Restoration of Class V lesions and cavities; Restoration of Class III cavities; Base! Core-build-up. When used as a core-build-up, 2/3 of the remaining coronal dentine or at least 2mm of circumferential coronal dentine should be left for retention.

Source page: https://510kreport.com/device/K101493
Methodology: https://510kreport.com/methodology