510(k) · Cleared
ClearedSpeedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dent4you AG · ELW Material, Impression
Cleared on Nov 15, 2024 as substantially equivalent to K220097 (Coltène/Whaledent AG, 2022) after a 98-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Nov 15, 2024
- Review
- 98 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943574 (1994). 10 ancestors in all, the oldest K811767 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 5 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 4 generations backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 3 generations backK113406 Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc. · 2012
- 2 generations backK152861 Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc. · 2016
- 1 generation backK220097 PRESIDENT The OriginalColtène/Whaledent AG · 2022
- This deviceK242360 Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty…Dent4you AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −5 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −4 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −3 | K113406 | Aquasil Ultra Smart Wetting Impression Material | Dentsply International, Inc. | 2012 | — |
| −2 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | 2016 | — |
| −1 | K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022 | — |
| 0 (this device) | K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex… | Dent4you AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K220097 | PRESIDENT The OriginalSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K220097 11 PRESIDENT The Original 11 ELW Device Desc… | 2022 |
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 30 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Speedex putty/putty soft - Primary impression in the putty-wash Impression technique - Pick-up impression in the simultaneous mixing technique - Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses Speedex light body - Correction material for the correction impression technique - Syringe material for the two-phase impression technique - Impression material for relining Speedex medium -…
Read the full statement (105 words)
Speedex putty/putty soft
- Primary impression in the putty-wash Impression technique
- Pick-up impression in the simultaneous mixing technique
- Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
Speedex light body
- Correction material for the correction impression technique
- Syringe material for the two-phase impression technique
- Impression material for relining
Speedex medium
- Complete and partial prosthetics, correction material for the correction impression technique
- Monophase impression technique, simultaneous mixing technique
- Liner impression material
Speedex Universal Activator
- Activator for Speedex putty; Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242360
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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