510(k) · Cleared
ClearedDental Mercury
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · ELY Mercury
Cleared on Jan 21, 2010 as substantially equivalent to K973548 (Aleaciones Dentales Zeyco, S.A. DE C.V., 1998) after a 63-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 21, 2010
- Review
- 63 days
- Class
- Class II
- Product code
- ELY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973548 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK973548 Mercury DentalAleaciones Dentales Zeyco, S.A. DE C.V. · 1998
- This deviceK093587 Dental MercuryDmg USA, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973548 | Mercury Dental | Aleaciones Dentales Zeyco, S.A. DE C.V. | 1998 | — |
| 0 (this device) | K093587 | Dental Mercury | Dmg USA, Inc. | 2010 | — |
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 ELY? 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 |
|---|---|---|---|
| * | K973548 | Mercury DentalSummary page 1…_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ MERCURY DENTAL K973548; ALEACIONES DENTALES RCURY DENTAL ~ZEYCO, S.A. DE C.V. DENTAL-QUECKSILBER ____… | 1998 |
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 ELY devicesELY Mercury: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ELY
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · ELY
Too few ELY 510(k)s in any year since 2007 to give a median.
Recalls per year · ELY
No recall names ELY since 2007.
Adverse event reports per year · ELY
1in 2024
MAUDE reports naming product code ELY, 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093587: Dental Mercury.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093587
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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