510(k) · Cleared
Recalled · 2003P2 Polyether
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, Inc. · ELW Material, Impression
Cleared on Apr 3, 2003 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 3, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- ELW
- Recalls
- 4
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK030318 P2 PolyetherHeraeus Kulzer, Inc. · 2003
- Descendant · cites it directly · 25 of its ownK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- Descendant · 3 generations on · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · 4 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK052090 Splash! Impression Material DeviceDiscus Dental, Inc. · 2005
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K040053Precision VPS Impression MaterialDiscus Dental, Inc. · 2004 · cites it directly25descendants
- K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006 · 2 generations on14descendants
- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · 3 generations on10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 4 generations on9descendants
- K052090Splash! Impression Material DeviceDiscus Dental, Inc. · 2005 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030318 | P2 Polyether | Heraeus Kulzer, Inc. | 2003 | — |
| +1 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| +2 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| +3 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +4 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +1 | K052090 | Splash! Impression Material Device | Discus Dental, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (26)
See all 262 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2003 | Not classified | Z-0624-05 | Other | Packaging defects could result in improper mixing ratios and unusable impressions. |
| Nov 1, 2003 | Not classified | Z-0626-05 | Other | Packaging defects could result in improper mixing ratios and unusable impressions. |
| Nov 1, 2003 | Not classified | Z-0627-05 | Other | Packaging defects could result in improper mixing ratios and unusable impressions. |
| Nov 1, 2003 | Not classified | Z-0625-05 | Other | Packaging defects could result in improper mixing ratios and unusable impressions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040053 (Discus Dental, Inc., 2004) has gone furthest, with 25 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?
P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030318: P2 Polyether.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030318
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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