510(k) · Cleared
ClearedTAKE 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Corp. · ELW Material, Impression
Cleared on Oct 7, 2009 after a 126-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 7, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK091613 TAKE 1Kerr Corp. · 2009
- Descendant · cites it directly · 3 of its ownK151150 ElementsPac-Dent International, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK223892 DentMix VPS Impression MaterialInnovative Product Brands, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK254152 Dia-X Sil Light BodyDiaDent Group International · 2026
- Descendant · 3 generations on · 0 of its ownK254142 Dia-X Sil Heavy BodyDiaDent Group International · 2026
- Descendant · cites it directly · 0 of its ownK130869 Take 1 AdvanceSybron Dental Specialties · 2013
Most influential descendants
Showing 5 of 5 · See all- K151150ElementsPac-Dent International, Inc. · 2015 · cites it directly3descendants
- K223892DentMix VPS Impression MaterialInnovative Product Brands, Inc. · 2023 · 2 generations on2descendants
- K254152Dia-X Sil Light BodyDiaDent Group International · 2026 · 3 generations on0descendants
- K254142Dia-X Sil Heavy BodyDiaDent Group International · 2026 · 3 generations on0descendants
- K130869Take 1 AdvanceSybron Dental Specialties · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091613 | TAKE 1 | Kerr Corp. | 2009 | — |
| +1 | K151150 | Elements | Pac-Dent International, Inc. | 2015 | — |
| +2 | K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | 2023 | — |
| +3 | K254152 | Dia-X Sil Light Body | DiaDent Group International | 2026 | — |
| +3 | K254142 | Dia-X Sil Heavy Body | DiaDent Group International | 2026 | — |
| +1 | K130869 | Take 1 Advance | Sybron Dental Specialties | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Kerr VPS Impression Material Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K151150 (Pac-Dent International, Inc., 2015) has gone furthest, with 3 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. 2009, 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?
Take I is an addition-cure vinyl polysiloxane dental impression material that is used for
all crown and bridge, edentulous, orthodontic and implant impression techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091613 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091613: TAKE 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091613
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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