# K192178: R&D Series Nova Compo N

- Pathway: 510(k) (Traditional)
- Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
- Decided: Dec 20, 2019 after 130 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: 3 generations back to K943168 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 5.
- K061860: Clearfil Majesty Esthetic, Kuraray Medical, Inc. (2006) Summary page 5.

## Indications for use
R&D Series Nova Compo N is a light–curing, radiopaque, nano–hybrid universal composite for anterior and posterior restorations. It is intended for professional use by below mentioned Indications for Use; · Restorations of deciduous teeth · Splinting of mobile teeth · Restoration in the posterior region (Classes I and II) · Anterior restorations (Classes III, IV) · Class V restorations (cervical caries, root erosion, wedge-shaped defects) · Extended fissure sealing in molars and premolars · Veneering of discoloured anterior teeth · Repair of composite and ceramic veneers

Source page: https://510kreport.com/device/K192178
Methodology: https://510kreport.com/methodology