# K014111: Rebilda SC

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Mar 6, 2002 after 82 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 K982201 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982201: Zenith Luxacore Automix Core Material (Multiple), Foremost Dental Mfg., Inc. (1998) Summary page 2.

## Indications for use
Rebilda SC is a self-curing, radiopaque, flowable composite intended to be used for core build-up in vital and non-vital teeth.

Source page: https://510kreport.com/device/K014111
Methodology: https://510kreport.com/methodology