510(k) · Cleared
ClearedAmdent 2030, Polisher/Scaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amdent AB · ELC Scaler, Ultrasonic
Cleared on Oct 20, 1993 after a 636-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.
- Decided
- Oct 20, 1993
- Review
- 636 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK920328 Amdent 2030, Polisher/ScalerAmdent AB · 1993
- Descendant · cites it directly · 30 of its ownK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- Descendant · 2 generations on · 17 of its ownK050710 Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005
- Descendant · 3 generations on · 14 of its ownK093723 Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010
- Descendant · 4 generations on · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 2 generations on · 12 of its ownK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K992504Ems Kermit(Ems Sa) Electro Medical Systems · 2000 · cites it directly30descendants
- K050710Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005 · 2 generations on17descendants
- K093723Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010 · 3 generations on14descendants
- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · 4 generations on13descendants
- K022328Ems Piezon Master 600Electro Medical Systems SA · 2002 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920328 | Amdent 2030, Polisher/Scaler | Amdent AB | 1993 | — |
| +1 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| +2 | K050710 | Minimaster Ultrasonic Scaler | E.M.S Electro Medical Systems S.A | 2005 | — |
| +3 | K093723 | Ems Minimaster Led | E.M.S Electro Medical Systems S.A | 2010 | — |
| +4 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +2 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992504 | Ems Kermit | 2000 | 30 |
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?
- Of its descendants, K992504 ((Ems Sa) Electro Medical Systems, 2000) has gone furthest, with 30 descendants of its own.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, 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 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K920328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920328: Amdent 2030, Polisher/Scaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920328
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026