510(k) · Cleared
ClearedDimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive
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 Mar 15, 1996 as substantially equivalent to K812116 (Espe-Premier Sales Co., 1981) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1981. 11 later devices descend from it.
- Decided
- Mar 15, 1996
- Review
- 36 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K812116 (1981). 2 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK812116 PermagumEspe-Premier Sales Co. · 1981
- This deviceK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- Descendant · cites it directly · 8 of its ownK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
- Descendant · 2 generations on · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · 2 generations on · 1 of its ownK090718 Bellus Shading Kit3M Espe AG Dental Products · 2009
- Descendant · cites it directly · 1 of its ownK991008 Dimension BiteEspe Dental AG · 1999
- Descendant · 3 generations on · 0 of its ownK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K974231Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998 · cites it directly8descendants
- K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · 2 generations on2descendants
- K090718Bellus Shading Kit3M Espe AG Dental Products · 2009 · 2 generations on1descendant
- K991008Dimension BiteEspe Dental AG · 1999 · cites it directly1descendant
- K133436Flash AR; Flash AR Quick3M Deutschland GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812116 | Permagum | Espe-Premier Sales Co. | 1981 | — |
| 0 (this device) | 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 | — |
| +2 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +2 | K090718 | Bellus Shading Kit | 3M Espe AG Dental Products | 2009 | — |
| +1 | K991008 | Dimension Bite | Espe Dental AG | 1999 | — |
| +3 | K133436 | Flash AR; Flash AR Quick | 3M Deutschland GmbH | 2014 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K812116 | PermagumSummary page 1…AND EFFECTIVENESS ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for silicone impression material, tradenamed Permagum® (K812116) and Permagum® Garant Light (K890720), to create slightly modified impression material, referred to by the tradenames Dimension®… | 1981 |
| Kept off the family tree | K890720 | Permagum® Garant Light Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…a 510(k) premarket notification for modifications to its 510(k) submissions for silicone impression material, tradenamed Permagum® (K812116) and Permagum® Garant Light (K890720), to create slightly modified impression material, referred to by the tradenames Dimension® Penta and Dimension® Garant L. For Di… | |
| * | K881838 | Modified Permagum AdhesiveSummary page 1…510(k) submission also includes adhesive material, tradenamed Polyvinyl Siloxane Adhesive, which is a modification p— of ESPE's previously cleared Permagum® Adhesive (K881838). The Feason for the modification in adhesive material is to enhance the user's ability to create a uniform layer of the adhesiv… | 1988 |
What descends from it? (11)
See all 113 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K974231 (Espe GmbH & Co. Kg., 1998) has gone furthest, with 8 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 | — |
What is it indicated for?
used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws.
Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.
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/K960547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960547: Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960547
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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