# K072150: Dimer Acid Derived Nano-Hybrid Composite Restorative Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Novocol, Inc.
- Decided: Sep 13, 2007 after 41 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 K920425 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946307: Cyrstalline L3 Multi-Use Hybrid Composite, Confi-Dental Products Co. (1995) Summary page 1.
- K920425: 3M Brand Restorative Z100, 3M Company (1992) Summary page 1.
- K051867: Grandio, Voco GmbH (2005) Summary page 1.

## Indications for use
"Dimer Acid Derived Nanohybrid Composite" is a light cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides simple esthetics since it is formulated in shades matching the VITA Lumin Shade guide. This low shrinkage nanohybrid composite can be used in all classes of direct dental restorations, Class 1,11, 111, IV, and V.

Source page: https://510kreport.com/device/K072150
Methodology: https://510kreport.com/methodology