510(k) · Cleared
ClearedBestaloy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
We Dong Myung Dental Industrial Co., Ltd. · EJJ Alloy, Amalgam
Cleared on Nov 12, 2003 as substantially equivalent to K902249 (Degussa AG, 1990) after a 15-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 12, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- EJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902249 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902249 Luxalloy 50 (Powder, Tablets, Predosed Capsules)Degussa AG · 1990
- This deviceK033434 BestaloyWe Dong Myung Dental Industrial Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902249 | Luxalloy 50 (Powder, Tablets, Predosed Capsules) | Degussa AG | 1990 | — |
| 0 (this device) | K033434 | Bestaloy | We Dong Myung Dental Industrial Co., Ltd. | 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 EJJ? 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 |
|---|---|---|---|
| * | K902249 | Luxalloy 50 (Powder, Tablets, Predosed Capsules)Summary page 1…Common Name -Amalgam Alloy Classification Name - Dental Materials -Alloys for dental amalgam 3. Predicate Device : LUX ALLOY^^, DEGUSSA AG K902249 4. Classifications Names 8,Citations : 21CFR 872.3050, EJJ, Dental materials -Alloys for dental amalgam. Class2… | 1990 |
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 EJJ devicesEJJ Alloy, Amalgam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJJ
FDA has decided no EJJ device since 2007.
Median 510(k) review, days · EJJ
Too few EJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · EJJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJJ
2in 2021
MAUDE reports naming product code EJJ, 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 | 49 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 22 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This is a dental amalgam for the filling of tooth cavities of Black’s Classes I and II
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033434: Bestaloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033434
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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