510(k) · Cleared
ClearedDENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set (Regular, Fast)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdi, Inc. · ELW Material, Impression
Cleared on Nov 7, 2022 as substantially equivalent to K152615 (Vericom Co., Ltd., 2016) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Nov 7, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943574 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 4 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 3 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 2 generations backK113406 Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc. · 2012
- 1 generation backK152615 Vonflex SVericom Co., Ltd. · 2016
- This deviceK222741 DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast)…Hdi, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −4 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −3 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −2 | K113406 | Aquasil Ultra Smart Wetting Impression Material | Dentsply International, Inc. | 2012 | — |
| −1 | K152615 | Vonflex S | Vericom Co., Ltd. | 2016 | — |
| 0 (this device) | K222741 | DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty… | Hdi, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K152615 | Vonflex SSummary page 4…72.3660 ·Class: 2 ·Classification Product Code: ELW 3. PREDICATE DEVICE DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast) : K152615 Vonflex STM, Vericom Co. Ltd DENU Putty Set(Regular, Fast) : K152518 Vonflex S Putty,… | 2016 |
| * | K152518 | Vonflex S PuttySummary page 4…ight Body(Regular, Fast), DENU Heavy Body(Regular, Fast) : K152615 Vonflex STM, Vericom Co. Ltd DENU Putty Set(Regular, Fast) : K152518 Vonflex S Putty, Vericom Co. Ltd 4. DEVICE DESCRIPTION The DENU family of silicone impression mate… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K152615.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
- Denture impression
- Model impression
DENU Putty Set(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222741: DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set (Regular, Fast).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222741
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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