510(k) · Cleared
ClearedPortadur P 2, Model #2031
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Edelmetalle GmbH & Co. · EJT Alloy, Gold-Based Noble Metal
Cleared on Nov 2, 2001 as substantially equivalent to K911539 (Metalor Dental USA Corp., 1991) after a 71-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 2, 2001
- Review
- 71 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911539 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911539 Aurofluid 3Metalor Dental USA Corp. · 1991
- This deviceK012843 Portadur P 2, Model #2031Wieland Edelmetalle GmbH & Co. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911539 | Aurofluid 3 | Metalor Dental USA Corp. | 1991 | — |
| 0 (this device) | K012843 | Portadur P 2, Model #2031 | Wieland Edelmetalle GmbH & Co. | 2001 | — |
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 EJT? 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 |
|---|---|---|---|
| * | K911539 | Aurofluid 3Summary page 1…r +49-7231-3705-219 +49-7231-357959 [email protected] 2001-07-21 Portadur P 2 Alloy, gold based, for clinical use EJT 872.3060 Class Il Aurofluid 3 K911539 Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for dental technicians to… | 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.
- 1 other device also cites its predicate K911539.
How does its category compare?
All EJT devicesEJT Alloy, Gold-Based Noble Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJT
FDA has decided no EJT device since 2007.
Median 510(k) review, days · EJT
Too few EJT 510(k)s in any year since 2007 to give a median.
Recalls per year · EJT
No recall names EJT since 2007.
Adverse event reports per year · EJT
1in 2017
MAUDE reports naming product code EJT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 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?
Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
Inlays/ Onlays
Crowns
Short span bridges
Long span bridges
Removable partials
and can be used for
Telescopic and milling work
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/K012843 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012843: Portadur P 2, Model #2031.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012843
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026