# K101540: Granitec Dual-Cure Core Build-UP, N'durance Dimer Core

- Pathway: 510(k) (Abbreviated)
- Applicant: Novocol Inc. Dba Septodont and Confi-Dental Produc
- Decided: Oct 29, 2010 after 148 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Granitec Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent. N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

Source page: https://510kreport.com/device/K101540
Methodology: https://510kreport.com/methodology