# K070583: Nano Composite

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Apr 16, 2007 after 46 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 K042819 (2004). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004) Summary page 1.

## Most influential descendants
- K080305: Nexcomp and Meta Etchant (2008), 1 descendant of its own
- K181689: Nexcomp (2018), 0 descendants of its own
- K163480: Renamel NANO +plus (2017), 0 descendants of its own

## Indications for use
NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.

Source page: https://510kreport.com/device/K070583
Methodology: https://510kreport.com/methodology