# K973694: Provil Novo

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Nov 24, 1997 after 59 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
I;rovil -nox;o is a silicone based, addition Curing impression material used for all inlay, crown and bridge, edentulous a partial impressions.

Source page: https://510kreport.com/device/K973694
Methodology: https://510kreport.com/methodology