510(k) · Cleared
ClearedVonflex S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vericom Co., Ltd. · ELW Material, Impression
Cleared on Nov 3, 2016 as substantially equivalent to K113406 (Dentsply International, Inc., 2012) after a 416-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 3, 2016
- Review
- 416 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943574 (1994). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 3 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 2 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 1 generation backK113406 Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc. · 2012
- This deviceK152615 Vonflex SVericom Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK233954 Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222741 DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast)…Hdi, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −3 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −2 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −1 | K113406 | Aquasil Ultra Smart Wetting Impression Material | Dentsply International, Inc. | 2012 | — |
| 0 (this device) | K152615 | Vonflex S | Vericom Co., Ltd. | 2016 | — |
| +1 | K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K113406 | Aquasil Ultra Smart Wetting Impression MaterialSummary page 4…Class II CFR Number – 872.3660 Product Code - ELW 3. Predicate Device: Aquasil Ultra Smart Wetting Impression Material, DENTSPLY International, K113406 4. Description: Vonflex S™, as the additional polymerization silicone type, is composed of a two component (base a… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K233954 (B&E Korea Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113406.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
- Impression of inlay, crown, bridge and partial denture etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152615: Vonflex S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152615
Report an extraction error
Are you the manufacturer?
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