510(k) · Cleared
ClearedECO E4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EJS Alloy, Other Noble Metal
Cleared on Sep 18, 2002 as substantially equivalent to K911675 (Metalor Dental USA Corp., 1991) after a 54-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 18, 2002
- Review
- 54 days
- Class
- Class II
- Product code
- EJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911675 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911675 Pagalin 2Metalor Dental USA Corp. · 1991
- This deviceK022469 ECO E4Wieland Dental + Technik GmbH & Co. KG · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911675 | Pagalin 2 | Metalor Dental USA Corp. | 1991 | — |
| 0 (this device) | K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
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 EJS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K911675 | Pagalin 2Summary page 1…EJS C.D.R section: 872.3060 Classification: Class II Legally marketed equivalent device: Pagalin 2 510(k) number: K911675 Device description Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate den… | 1991 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EJS devicesEJS Alloy, Other Noble Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJS
FDA has decided no EJS device since 2007.
Median 510(k) review, days · EJS
Too few EJS 510(k)s in any year since 2007 to give a median.
Recalls per year · EJS
No recall names EJS since 2007.
Adverse event reports per year · EJS
No MAUDE report names EJS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Eco..E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
Inlays/oniays
Crowns
Short span bridges
Long span bridges
Eco E4 can be veneered with suitable dental comp&ites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022469: ECO E4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022469
Report an extraction error
Are you the manufacturer?
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