510(k) · Cleared
ClearedPecd-01 and Pecd Quick-01
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 Mar 26, 2008 as substantially equivalent to K994192 (Espe Dental AG, 2000) and 2 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 26, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954192 (1995). 9 ancestors in all, the oldest K953027 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK954192 Impregum PentaEspe GmbH & Co. Kg. · 1995
- 3 generations backK992897 Impregum PentaEspe Dental AG · 1999
- 2 generations backK994192 Impregum Penta M MonosoftEspe Dental AG · 2000
- 1 generation backK032001 Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products · 2003
- This deviceK080514 Pecd-01 and Pecd Quick-013M Espe AG Dental Products · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954192 | Impregum Penta | Espe GmbH & Co. Kg. | 1995 | — |
| −3 | K992897 | Impregum Penta | Espe Dental AG | 1999 | — |
| −2 | K994192 | Impregum Penta M Monosoft | Espe Dental AG | 2000 | — |
| −1 | K032001 | Poly Q (Garant L, Penta M, Penta H) | 3M Espe AG Dental Products | 2003 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2000 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994192 | Impregum Penta M MonosoftSummary page 1…n Name:.............................Dental impression material Predicate Devices ImpregUMTM PentaTm M Monosoft by 3M ES PE .... K994192 Poly Q Penta M by 3M ESPE ................... K032001 Ramitec Pent… | 2000 |
| * | K032001 | Poly Q (Garant L, Penta M, Penta H)Summary page 1…ices ImpregUMTM PentaTm M Monosoft by 3M ES PE .... K994192 Poly Q Penta M by 3M ESPE ................... K032001 Ramitec Penta by 3M ESPE .................... K952693 Special 51C(k) PECD-01, PECD Q… | 2003 |
| * | K952693 | Ramitec PentaSummary page 1…Poly Q Penta M by 3M ESPE ................... K032001 Ramitec Penta by 3M ESPE .................... K952693 Special 51C(k) PECD-01, PECD Quick-01… | 1995 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K994192.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant irripressions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080514: Pecd-01 and Pecd Quick-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080514
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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