510(k) · Cleared
ClearedFlash AR; Flash AR 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 Mar 7, 2014 as substantially equivalent to K131404 (3M Deutschland GmbH, 2013) after a 119-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Mar 7, 2014
- Review
- 119 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K812116 (1981). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK812116 PermagumEspe-Premier Sales Co. · 1981
- 3 generations backK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- 2 generations backK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
- 1 generation backK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- This deviceK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K812116 | Permagum | Espe-Premier Sales Co. | 1981 | — |
| −3 | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | Espe GmbH & Co. Kg. | 1996 | — |
| −2 | K974231 | Position Penta, Position Penta Quick | Espe GmbH & Co. Kg. | 1998 | — |
| −1 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| 0 (this device) | K133436 | Flash AR; Flash AR Quick | 3M Deutschland GmbH | 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 |
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 |
|---|---|---|---|
| * | K131404 | Flash AR Penta / Flash AR Penta QuickSummary page 1…n material Predicate Devices Flash AR Pentatm , Flash AR Pentam Quick by 3M Deutschland GmbH, Germany ......... K13 1404 Amendment 510(k) Submission' Flash AR & Flash AR Quick; Dec. 03, 2013… | 2013 |
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 33 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K131404.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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/K133436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133436: Flash AR; Flash AR Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133436
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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