510(k) · Cleared
ClearedPorta SMK 82, Model 2032
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Edelmetalle GmbH & Co. · EJS Alloy, Other Noble Metal
Cleared on Nov 1, 2001 as substantially equivalent to K921419 (Degussa AG, 1992) after a 70-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Nov 1, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- EJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921419 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921419 Deva PlusDegussa AG · 1992
- This deviceK012828 Porta SMK 82, Model 2032Wieland Edelmetalle GmbH & Co. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921419 | Deva Plus | Degussa AG | 1992 | — |
| 0 (this device) | K012828 | Porta SMK 82, Model 2032 | 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 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 |
|---|---|---|---|
| * | K921419 | Deva PlusSummary page 1…K 82 Alloy, gold based, for clinical use Product code: EJT C.D.R section: 872.3060 Classification: Class Legally marketed equivalent device: Deva Plus 510(k) nhumber: K 921419 Device description Porta SMK 82 is a gold-palladium ceramic alloy with high contents of noble metals (90.5%), intended for denta… | 1992 |
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?
Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
Partial crowns
Crowns
Short span bridges
Long span bridges
Removable partials
and can be used for
Telescopic and milling work
Porta SMK 82 can be veneered with suitable dental ceramics as well as with dental-composites.
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/K012828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012828: Porta SMK 82, Model 2032.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012828
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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