510(k) · Cleared
ClearedPosition Penta, Position Penta Quick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH & Co. Kg. · ELW Material, Impression
Cleared on Jan 29, 1998 as substantially equivalent to K960547 (Espe GmbH & Co. Kg., 1996) after a 78-day review. Its family tree reaches back 2 generations to 1981. 8 later devices descend from it.
- Decided
- Jan 29, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K812116 (1981). 3 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK812116 PermagumEspe-Premier Sales Co. · 1981
- 1 generation backK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- This deviceK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
- Descendant · cites it directly · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · cites it directly · 1 of its ownK090718 Bellus Shading Kit3M Espe AG Dental Products · 2009
- 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
- Descendant · 2 generations on · 0 of its ownK130604 Universal Paste Stains and GlazePrismatik Dentalcraft, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · cites it directly2descendants
- K090718Bellus Shading Kit3M Espe AG Dental Products · 2009 · cites it directly1descendant
- K133436Flash AR; Flash AR Quick3M Deutschland GmbH · 2014 · 2 generations on0descendants
- K133400Flash Bite3M Espe AG · 2014 · 2 generations on0descendants
- K130604Universal Paste Stains and GlazePrismatik Dentalcraft, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K812116 | Permagum | Espe-Premier Sales Co. | 1981 | — |
| −1 | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | Espe GmbH & Co. Kg. | 1996 | — |
| 0 (this device) | K974231 | Position Penta, Position Penta Quick | Espe GmbH & Co. Kg. | 1998 | — |
| +1 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +1 | K090718 | Bellus Shading Kit | 3M Espe AG Dental Products | 2009 | — |
| +2 | K133436 | Flash AR; Flash AR Quick | 3M Deutschland GmbH | 2014 | — |
| +2 | K133400 | Flash Bite | 3M Espe AG | 2014 | — |
| +2 | K130604 | Universal Paste Stains and Glaze | Prismatik Dentalcraft, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveSummary page 1…S ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submission for polyvinyl siloxane impression material, tradenamed Dimension® Penta (K960547), now called Dimension® Penta H.Y The modifications have been made to create slightly modified impression materials, referred to… | 1996 |
What descends from it? (8)
5 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 17 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131404 (3M Deutschland GmbH, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K960547.
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 | — |
What is it indicated for?
Impressions for temporary restorations
Preliminary impressions (all types)
Impressions of opposing jaws
Impressions for orthodontic models
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974231: Position Penta, Position Penta Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974231
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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