# K080480: Nanocomposite Restorative Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: May 30, 2008 after 98 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 K042913 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 2.
- (no number) SternOmega Composite LC: named in the summary without a submission number
- (no number) Sternomega Composite LC: named in the summary without a submission number

## Most influential descendants
- K171772: Ecosite Bulk Fill (2018), 0 descendants of its own

## Indications for use
The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows: 1. Nanocomposite is indicated for: Restorations of all cavity classes Fabrication of direct inlays, onlays and indirect veneers Core build-up after tooth preparation with the root canal post Machinable Composite for Restorations Indirect Inlays/Onlays 2. Nanocomposite Flowable is indicated for: Small fillings of cavity classes III, IV and V Minimally invasive fillings for deciduous teeth (all cavity classes) Splinting of teeth 3. MDP One Bottle Bond is indicated for: Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel)

Source page: https://510kreport.com/device/K080480
Methodology: https://510kreport.com/methodology