# K073539: Provisa Cem

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Jan 31, 2008 after 45 days
- Product code: EMB (Zinc Oxide Eugenol)
- Device class: 1
- Regulation: 21 CFR 872.3275
- 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. The FDA summary names no predicate by number.

## Indications for use
PROVISA CEM is intended for the cementation of temporary crowns and bridges. PROVISA CEM is free of eugenol. After its removal, it will also not inhibit the polymerisation of a composite cement or composite filling material.

Source page: https://510kreport.com/device/K073539
Methodology: https://510kreport.com/methodology