510(k) · Cleared
ClearedImprint Vinyl Polysiloxane Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · ELW Material, Impression
Cleared on Aug 11, 1988 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Aug 11, 1988
- Review
- 42 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK882690 Imprint Vinyl Polysiloxane Impression Material3M Company · 1988
- Descendant · cites it directly · 5 of its ownK963766 3M Proplus System3M Company · 1996
- Descendant · 2 generations on · 4 of its ownK120438 Flash (Different Materials)3M Deutschland GmbH · 2012
- Descendant · 3 generations on · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · cites it directly · 0 of its ownK254112 Dia-X Sil BiteDiaDent Group International · 2026
- Descendant · cites it directly · 0 of its ownK181604 Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteHrs Co., Ltd. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K9637663M Proplus System3M Company · 1996 · cites it directly5descendants
- K120438Flash (Different Materials)3M Deutschland GmbH · 2012 · 2 generations on4descendants
- K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · 3 generations on2descendants
- K254112Dia-X Sil BiteDiaDent Group International · 2026 · cites it directly0descendants
- K181604Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteHrs Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882690 | Imprint Vinyl Polysiloxane Impression Material | 3M Company | 1988 | — |
| +1 | K963766 | 3M Proplus System | 3M Company | 1996 | — |
| +2 | K120438 | Flash (Different Materials) | 3M Deutschland GmbH | 2012 | — |
| +3 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +1 | K254112 | Dia-X Sil Bite | DiaDent Group International | 2026 | — |
| +1 | K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | Hrs Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
4 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, K963766 (3M Company, 1996) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K882690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882690: Imprint Vinyl Polysiloxane 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/K882690
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026