510(k) · Cleared
ClearedKeradec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EJT Alloy, Gold-Based Noble Metal
Cleared on Oct 31, 2002 as substantially equivalent to K851872 (Heraeus Dental Gold Corp., 1985) after an 83-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Oct 31, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- EJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851872 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK851872 Blengold SpecialHeraeus Dental Gold Corp. · 1985
- This deviceK022663 KeradecWieland Dental + Technik GmbH & Co. KG · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851872 | Blengold Special | Heraeus Dental Gold Corp. | 1985 | — |
| 0 (this device) | K022663 | Keradec | Wieland Dental + Technik GmbH & Co. KG | 2002 | — |
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 |
|---|---|---|---|
| * | K851872 | Blengold SpecialSummary page 1…EJT C.D.R section: 872.3060 Classification: Class II Legally marketed equivalent device: Blendgold Special 510(k) number: K 851872 Device description KERADEC is a fuse-on gold paste, which can be used by dental technicians to fabricate dental appliances for… | 1985 |
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 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?
KERADEC is a fuse-on gold paste, which can be used by dental technicians to manufacture dental appliances for patients.
It is intended for gold coating of white metal surfaces in cervical areas, elimination of casting cavities, gold coating of occlusal surfaces and inlay imitations.
In addition, it can be used within the AGC electroforming technique to manufacture AGC Bridges with the sintering procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022663: Keradec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022663
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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