510(k) · Cleared
ClearedArgedent 77PF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argen Precious Metals, Inc. · EJT Alloy, Gold-Based Noble Metal
Cleared on Jan 26, 1994 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 26, 1994
- Review
- 72 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK935507 Argedent 77PFArgen Precious Metals, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK023389 Porta Geo TIWieland Dental + Technik GmbH & Co. KG · 2002
- Descendant · 2 generations on · 0 of its ownK040672 Porta ReflexWieland Dental + Technik GmbH & Co. KG · 2004
- Descendant · cites it directly · 0 of its ownK012834 Porta Geo TI Model #2004Wieland Edelmetalle GmbH & Co. · 2001
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935507 | Argedent 77PF | Argen Precious Metals, Inc. | 1994 | — |
| +1 | K023389 | Porta Geo TI | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
| +2 | K040672 | Porta Reflex | Wieland Dental + Technik GmbH & Co. KG | 2004 | — |
| +1 | K012834 | Porta Geo TI Model #2004 | Wieland Edelmetalle GmbH & Co. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 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? (3)
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, K023389 (Wieland Dental + Technik GmbH & Co. KG, 2002) has gone furthest, with 1 descendant 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/K935507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935507: Argedent 77PF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935507
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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