510(k) · Cleared
ClearedPortadur P2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EJT Alloy, Gold-Based Noble Metal
Cleared on Dec 11, 2002 as substantially equivalent to K911539 (Metalor Dental USA Corp., 1991) after a 63-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Dec 11, 2002
- Review
- 63 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 deviceK023395 Portadur P2Wieland 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 | K911539 | Aurofluid 3 | Metalor Dental USA Corp. | 1991 | — |
| 0 (this device) | K023395 | Portadur P2 | 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 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…EJT C.D.R section: 872.3060 Classification: Class II Legally marketed equivalent device: Aurofluid 3 510(k) number: K911539 Device description Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for… | 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 P2 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
In addition Portadur P2, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of identical or comparable alloys are joined to form dental restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023395: Portadur P2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023395
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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