# K152004: Nanova Universal Composite

- Pathway: 510(k) (Traditional)
- Applicant: Nanova Biomaterials, Inc.
- Decided: Nov 17, 2015 after 120 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K083610 (2008). 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)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 4.

## Indications for use
Nanova Universal Dental Composite is indicated for use in: Direct anterior and posterior restorations (including occlusal surfaces) Core Build-ups Splinting Indirect restorations including inlays, onlays and veneers

Source page: https://510kreport.com/device/K152004
Methodology: https://510kreport.com/methodology