510(k) · Cleared
ClearedVitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Austenal, Inc. · EJH Alloy, Metal, Base
Cleared on Apr 21, 1997 as substantially equivalent to K880875 (Austenal Dental, Inc., 1988) after a 90-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Apr 21, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- EJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880875 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880875 Vitallium Equipoise AlloyAustenal Dental, Inc. · 1988
- This deviceK970205 Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome…Austenal, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880875 | Vitallium Equipoise Alloy | Austenal Dental, Inc. | 1988 | — |
| 0 (this device) | K970205 | Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy | Austenal, Inc. | 1997 | — |
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 EJH? 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 |
|---|---|---|---|
| * | K880875 | Vitallium Equipoise AlloySummary page 1…ntially, equivalent products for these products are preammendment devices Vitallium Alloy, Vitallium 2 Alloy, and Vitallium Equipoise Alloy cover by 510 (K) Notification K 880875. Vitallium 2000 Alloy, Vitallium 2000 Plus Alloy, Cobalt Chrome Casting Alloy, and the predicate products comply with the compos… | 1988 |
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 EJH devicesEJH Alloy, Metal, Base: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · EJH
Too few EJH 510(k)s in any year since 2007 to give a median.
Recalls per year · EJH
No recall names EJH since 2007.
Adverse event reports per year · EJH
1in 2018
MAUDE reports naming product code EJH, 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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 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?
The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks.
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/K970205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970205: Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970205
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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