# K073554: NEUN

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer,GmbH
- Decided: Feb 4, 2008 after 48 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (2026), 0 descendants of its own

## Indications for use
Direct restorations of Black classes I - V Direct composite veneers Shape corrections of teeth Temporary splinting of teeth loosened by trauma or periodontal disease Indirect restorations (inlays, veneers) Restoration of primary teeth Core build-up Temporary repairs of composite and ceramics (in combination with a suitable repair system)

Source page: https://510kreport.com/device/K073554
Methodology: https://510kreport.com/methodology