510(k) · Cleared
ClearedHydrogum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhermack Dental Production · ELW Material, Impression
Cleared on Aug 22, 1995 after a 679-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 22, 1995
- Review
- 679 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK935898 HydrogumZhermack Dental Production · 1995
- Descendant · cites it directly · 5 of its ownK984246 Prompt L-PopEspe Dental AG · 1999
- Descendant · 2 generations on · 1 of its ownK992966 ReferenceEspe Dental AG · 1999
- Descendant · 2 generations on · 0 of its ownK210945 Ultra SEPReliance Orthodontic Products, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK071688 Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK993566 PromptflowEspe Dental AG · 1999
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984246Prompt L-PopEspe Dental AG · 1999 · cites it directly5descendants
- K992966ReferenceEspe Dental AG · 1999 · 2 generations on1descendant
- K210945Ultra SEPReliance Orthodontic Products, Inc. · 2021 · 2 generations on0descendants
- K071688Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007 · 2 generations on0descendants
- K993566PromptflowEspe Dental AG · 1999 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935898 | Hydrogum | Zhermack Dental Production | 1995 | — |
| +1 | K984246 | Prompt L-Pop | Espe Dental AG | 1999 | — |
| +2 | K992966 | Reference | Espe Dental AG | 1999 | — |
| +2 | K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | 2021 | — |
| +2 | K071688 | Reliance S.E.P. | Reliance Orthodontic Products, Inc. | 2007 | — |
| +3 | K993566 | Promptflow | Espe Dental AG | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984246 | Prompt L-Pop | 1999 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984246 (Espe Dental AG, 1999) has gone furthest, with 5 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K935898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935898: Hydrogum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935898
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026