# K011801: Futura Topcap Non Gamma-2

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Aug 16, 2001 after 69 days
- Product code: EJJ (Alloy, Amalgam)
- Device class: 2
- Regulation: 21 CFR 872.3070
- 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 TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class | Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.

Source page: https://510kreport.com/device/K011801
Methodology: https://510kreport.com/methodology