510(k) · Cleared
ClearedBioporta G, Model 2052
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 1, 2001 as substantially equivalent to K952122 (Metalor Dental USA Corp., 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Nov 1, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952122 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952122 V-Gnathos PlusMetalor Dental USA Corp. · 1995
- This deviceK012826 Bioporta G, Model 2052Wieland Edelmetalle GmbH & Co. · 2001
- Descendant · cites it directly · 0 of its ownK023392 Agc Special AlloyWieland Dental + Technik GmbH & Co. KG · 2002
- Descendant · cites it directly · 0 of its ownK020347 Agc SpeziallegierungWieland Edelmetalle GmbH & Co. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952122 | V-Gnathos Plus | Metalor Dental USA Corp. | 1995 | — |
| 0 (this device) | K012826 | Bioporta G, Model 2052 | Wieland Edelmetalle GmbH & Co. | 2001 | — |
| +1 | K023392 | Agc Special Alloy | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
| +1 | K020347 | Agc Speziallegierung | Wieland Edelmetalle GmbH & Co. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
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 |
|---|---|---|---|
| * | K952122 | V-Gnathos PlusSummary page 1…+49-7231-3705-219 +49-7231-357959 [email protected] 2001-07-21 BioPorta G Alloy, gold based, for clinical use EJT 872.3060 Class Il V-Gnathos Plus K952122 BioPorta G is an extra-hard dental alloy with high contents of gold and platinum (97 %) intended for dental technicians to fabri… | 1995 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
BioPorta G is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
Inlays/ Onlays
Partial crowns
Crowns
Short span bridges
Long span bridges
Removable partials
and can be used for
Telescopic and milling work
BioPorta G 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/K012826 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012826: Bioporta G, Model 2052.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012826
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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