510(k) · Cleared
ClearedV-Gnathos Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metalor Dental USA Corp. · EJT Alloy, Gold-Based Noble Metal
Cleared on Jun 6, 1995 after a 32-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 6, 1995
- Review
- 32 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK952122 V-Gnathos PlusMetalor Dental USA Corp. · 1995
- Descendant · cites it directly · 2 of its ownK012826 Bioporta G, Model 2052Wieland Edelmetalle GmbH & Co. · 2001
- Descendant · cites it directly · 0 of its ownK023391 Bioporta GWieland Dental + Technik GmbH & Co. KG · 2002
- Descendant · 2 generations on · 0 of its ownK023392 Agc Special AlloyWieland Dental + Technik GmbH & Co. KG · 2002
- Descendant · 2 generations on · 0 of its ownK020347 Agc SpeziallegierungWieland Edelmetalle GmbH & Co. · 2002
Most influential descendants
Showing 4 of 4 · See all- K012826Bioporta G, Model 2052Wieland Edelmetalle GmbH & Co. · 2001 · cites it directly2descendants
- K023391Bioporta GWieland Dental + Technik GmbH & Co. KG · 2002 · cites it directly0descendants
- K023392Agc Special AlloyWieland Dental + Technik GmbH & Co. KG · 2002 · 2 generations on0descendants
- K020347Agc SpeziallegierungWieland Edelmetalle GmbH & Co. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952122 | V-Gnathos Plus | Metalor Dental USA Corp. | 1995 | — |
| +1 | K012826 | Bioporta G, Model 2052 | Wieland Edelmetalle GmbH & Co. | 2001 | — |
| +1 | K023391 | Bioporta G | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
| +2 | K023392 | Agc Special Alloy | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
| +2 | K020347 | Agc Speziallegierung | Wieland Edelmetalle GmbH & Co. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K012826 (Wieland Edelmetalle GmbH & Co., 2001) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K952122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952122: V-Gnathos Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952122
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026