# K991974: Futura Glass Ionomer Silver Reinforced

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Sep 17, 1999 after 98 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
FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries: Class I and II cavities in deciduous teeth. Repair of amalgam restored teeth (fractured restoration or tooth). Class I and II cavities in selected permanent teeth. Lining under amalgam or posterior composite restorations. Cavities where radiopacity is a prime requirement. Core build up material under crowns. On root surface for locating overdentures. Long term temporary replacement of cusps Repairs to crown margins. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Source page: https://510kreport.com/device/K991974
Methodology: https://510kreport.com/methodology