# K083739: Hydrorise and Hydrosystem

- Pathway: 510(k) (Traditional)
- Applicant: Zhermack S.P.A.
- Decided: Mar 26, 2009 after 100 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 3 (0 Class I)
- 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.

## Recalls of this device
- Nov 9, 2016 · Class II · Z-0717-2017: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
- Nov 9, 2016 · Class II · Z-0718-2017: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
- Nov 9, 2016 · Class II · Z-0719-2017: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

## Indications for use
HYDRORISE is a conventional two-component (base/catalyst) polyvinylsiloxane (PVS) dental impression material intended to be placed on preformed impression tray and used to reproduce the structure of a patient's teeth and gums. HYDROSYSTEM, an accessory to Hydrorise dental impression material, is intended to be applied to conventional substrates, including tooth preparations, ceramics, composites, metal core build-up material, and provides a uniform surface wetting with reduced surface tension before applying traditional dental impression material.

Source page: https://510kreport.com/device/K083739
Methodology: https://510kreport.com/methodology