510(k) · Cleared
Recalled · Class II · 2016Hydrorise and Hydrosystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhermack S.P.A. · ELW Material, Impression
Cleared on Mar 26, 2009 after a 100-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 3 times.
- Decided
- Mar 26, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- ELW
- Recalls
- 3
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2016 | Class II | Z-0717-2017 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083739 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083739: Hydrorise and Hydrosystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083739
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026