510(k) · Cleared
ClearedCera R Plus Alloy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · EJT Alloy, Gold-Based Noble Metal
Cleared on Sep 30, 2003 as substantially equivalent to K951780 (Degussa Corp., 1995) after a 64-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 30, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951780 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951780 Stabilor NF IVDegussa Corp. · 1995
- This deviceK032319 Cera R Plus AlloyDentsply International · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951780 | Stabilor NF IV | Degussa Corp. | 1995 | — |
| 0 (this device) | K032319 | Cera R Plus Alloy | Dentsply International | 2003 | — |
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 |
|---|---|---|---|
| * | K951780 | Stabilor NF IVSummary page 1…CERA R PLUS ALLOY CLASSIFICATION NAME: Gold based alloy for clinical use (872.3060) PREDICATE DEVICES: Stabilor NF IV alloy K95 1780 DEVICE DESCRIPTION: CERA R PLUS ALLOY is a gold-based dental alloy for prosthodontic devices. INTENDED USE: C… | 1995 |
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.
- 1 other device also cites its predicate K951780.
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?
Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032319: Cera R Plus Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032319
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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