510(k) · Cleared
ClearedFlash AR Penta / Flash AR Penta Quick
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 30, 2013 as substantially equivalent to K974231 (Espe GmbH & Co. Kg., 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1981. 2 later devices descend from it.
- Decided
- May 30, 2013
- Review
- 15 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K812116 (1981). 13 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK812116 PermagumEspe-Premier Sales Co. · 1981
- 2 generations backK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- 1 generation backK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
- This deviceK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · cites it directly · 0 of its ownK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014
- Descendant · cites it directly · 0 of its ownK133400 Flash Bite3M Espe AG · 2014
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 |
|---|---|---|---|---|---|
| −3 | K812116 | Permagum | Espe-Premier Sales Co. | 1981 | — |
| −2 | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | Espe GmbH & Co. Kg. | 1996 | — |
| −1 | K974231 | Position Penta, Position Penta Quick | Espe GmbH & Co. Kg. | 1998 | — |
| 0 (this device) | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +1 | K133436 | Flash AR; Flash AR Quick | 3M Deutschland GmbH | 2014 | — |
| +1 | K133400 | Flash Bite | 3M Espe AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K974231 | Position Penta, Position Penta QuickSummary page 1…Predicate Devices Position PentaTM & Position PentarM Quick by 3M Deutsch land GmbH, Germany.............................. K974231I Flash by 3M Deutschland GmnbH, Germany.............................. K120438 5 10(k)… | 1998 |
| * | K120438 | Flash (Different Materials)Summary page 1…ch land GmbH, Germany.............................. K974231I Flash by 3M Deutschland GmnbH, Germany.............................. K120438 5 10(k) Submission: Flash AR Penta & Flash AR Penta Quick; March 06, 2013… | 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 32 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K133436 (3M Deutschland GmbH, 2014) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K974231.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Impressions for the production of temporary restorations
All types of preliminary impressions
Impressions of the opposing jaw
Impressions for orthodontic models
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131404: Flash AR Penta / Flash AR Penta Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131404
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