# K080130: Occlufast Cad

- Pathway: 510(k) (Special)
- Applicant: Zhermack S.P.A.
- Decided: Mar 14, 2008 after 56 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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
Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices. Occlufast CAD has been developed for use with CAD/CAM systems.

Source page: https://510kreport.com/device/K080130
Methodology: https://510kreport.com/methodology