510(k) · Cleared
ClearedFlash (Different Materials)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Deutschland GmbH · ELW Material, Impression
Cleared on May 2, 2012 as substantially equivalent to K051797 (3M Espe AG Dental Products, 2005) and 2 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it.
- Decided
- May 2, 2012
- Review
- 79 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K863288 (1986). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK863288 Hydrophilic ReprosilDentsply Intl. · 1986
- 1 generation backK963766 3M Proplus System3M Company · 1996
- This deviceK120438 Flash (Different Materials)3M Deutschland GmbH · 2012
- Descendant · cites it directly · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · cites it directly · 0 of its ownK140602 Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014
- Descendant · 2 generations on · 0 of its ownK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK133400 Flash Bite3M Espe AG · 2014
Most influential descendants
Showing 4 of 4 · See all- K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · cites it directly2descendants
- K140602Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014 · cites it directly0descendants
- K133436Flash AR; Flash AR Quick3M Deutschland GmbH · 2014 · 2 generations on0descendants
- K133400Flash Bite3M Espe AG · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863288 | Hydrophilic Reprosil | Dentsply Intl. | 1986 | — |
| −1 | K963766 | 3M Proplus System | 3M Company | 1996 | — |
| 0 (this device) | K120438 | Flash (Different Materials) | 3M Deutschland GmbH | 2012 | — |
| +1 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +1 | K140602 | Flash Penta MB Quick, Flash MB Quick | 3M Espe AG | 2014 | — |
| +2 | K133436 | Flash AR; Flash AR Quick | 3M Deutschland GmbH | 2014 | — |
| +2 | K133400 | Flash Bite | 3M Espe AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K051797 | Future Wash/YpsSummary page 2…Common Name: ........................................ Dental impression material Predicate Devices Future Wash/YPS by 3M Deutschland GmnbH, Germany....... K051797 Dimension Penta H by 3M Deutschland GmbH, Germany .... K000591 3M ProPlus System by 3M ESPE Dental Products,… | 2005 |
| * | K000591 | Dimension Penta H, Dimension Penta H QuickSummary page 2…erial Predicate Devices Future Wash/YPS by 3M Deutschland GmnbH, Germany....... K051797 Dimension Penta H by 3M Deutschland GmbH, Germany .... K000591 3M ProPlus System by 3M ESPE Dental Products, U.S.A. ... K963766 Description for the Premarket Notification… | 2000 |
| * | K963766 | 3M Proplus SystemSummary page 2…y....... K051797 Dimension Penta H by 3M Deutschland GmbH, Germany .... K000591 3M ProPlus System by 3M ESPE Dental Products, U.S.A. ... K963766 Description for the Premarket Notification Flash materials are classified as impression materials (21 C.F.R. § 872.3660)… | 1996 |
What descends from it? (4)
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 26 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K131404 (3M Deutschland GmbH, 2013) has gone furthest, with 2 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. 2012, 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?
Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g.: crown, bridge, inlay and onlay preparations).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120438: Flash (Different Materials).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120438
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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