510(k) · Cleared
ClearedHygedent Alginate Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygedent, Inc. · ELW Material, Impression
Cleared on May 21, 2014 as substantially equivalent to K023466 (Cavex Holland BV, 2002) after a 128-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- May 21, 2014
- Review
- 128 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023466 (2002). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K170812HygePLUS Alginate Impression MaterialHygedent, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023466 | Tulip Alginate Impression Material | Cavex Holland BV | 2002 | — |
| 0 (this device) | K140074 | Hygedent Alginate Impression Material | Hygedent, Inc. | 2014 | — |
| +1 | K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023466 | Tulip Alginate Impression MaterialSummary page 1…Name: Classification Names: Material, Impression Regulation number: CFR 872.3660 Product Code: ELW Predicate Device(s): K(023466 Device Description: Hygedent Alginate Impression Material is a dust free alginate impression… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170812 | HygePLUS Alginate Impression Material | 2017 | 0 |
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?
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Hygedent Alginate Impression Material is irreversible hydrocolloids for dental Impressions used by the dentist to take the anatomical data of the patient's mouth. The device IsIntended to provide models for study and for production of restorative prosthetic devices, such as gold Inlays and dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140074: Hygedent Alginate Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026