510(k) · Cleared
ClearedPoly Q (Garant L, Penta M, Penta H)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · ELW Material, Impression
Cleared on Aug 11, 2003 as substantially equivalent to K994190 (Espe Dental AG, 2000) and 2 other predicates after a 45-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 11, 2003
- Review
- 45 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K954192 (1995). 7 ancestors in all, the oldest K953027 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954192 Impregum PentaEspe GmbH & Co. Kg. · 1995
- 2 generations backK992897 Impregum PentaEspe Dental AG · 1999
- 1 generation backK994192 Impregum Penta M MonosoftEspe Dental AG · 2000
- This deviceK032001 Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products · 2003
- Descendant · cites it directly · 0 of its ownK173318 Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH · 2017
- Descendant · cites it directly · 0 of its ownK080514 Pecd-01 and Pecd Quick-013M Espe AG Dental Products · 2008
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 | K954192 | Impregum Penta | Espe GmbH & Co. Kg. | 1995 | — |
| −2 | K992897 | Impregum Penta | Espe Dental AG | 1999 | — |
| −1 | K994192 | Impregum Penta M Monosoft | Espe Dental AG | 2000 | — |
| 0 (this device) | K032001 | Poly Q (Garant L, Penta M, Penta H) | 3M Espe AG Dental Products | 2003 | — |
| +1 | K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | 2017 | — |
| +1 | K080514 | Pecd-01 and Pecd Quick-01 | 3M Espe AG Dental Products | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K994190 | Impregum Garant L DuosoftSummary page 2…Common Name: Dental impression material Predicate Device: Poly Q GarantTML: ImpregumTMGarantTML DuoSoft, K 994 190 Poly Q PentaTMM: ImpregumTMPentaTMM Monosoft, K 994 192 Poly Q PentaTMH:… | 2000 |
| * | K994192 | Impregum Penta M MonosoftSummary page 2…e Device: Poly Q GarantTML: ImpregumTMGarantTML DuoSoft, K 994 190 Poly Q PentaTMM: ImpregumTMPentaTMM Monosoft, K 994 192 Poly Q PentaTMH: ImpregumTMPentaTMH DuoSofi, K 994193 Description for the Premarket Notification… | 2000 |
| * | K994193 | Impregum Penta DuosoftSummary page 2…K 994 190 Poly Q PentaTMM: ImpregumTMPentaTMM Monosoft, K 994 192 Poly Q PentaTMH: ImpregumTMPentaTMH DuoSofi, K 994193 Description for the Premarket Notification Poly Q is classified as Impression material ( 21 C.F.R. 4 872.3660) because it i… | 2000 |
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 8 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K173318 (3M Deutschland GmbH, 2017) has gone furthest, with 0 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?
Poly Q Garant L:
Wash material for dual phase impression techniques.
Poly Q Penta M:
Impression material for monophase technique.
Poly Q Penta H:
Tray material for dual phase impression techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032001: Poly Q (Garant L, Penta M, Penta H).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032001
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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