510(k) · Cleared
ClearedMinimaster Ultrasonic Scaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.M.S Electro Medical Systems S.A · ELC Scaler, Ultrasonic
Cleared on Mar 30, 2005 as substantially equivalent to K992504 ((Ems Sa) Electro Medical Systems, 2000) after a 12-day review. Its family tree reaches back 2 generations to 1990. 17 later devices descend from it.
- Decided
- Mar 30, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896749 (1990). 4 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 1 generation backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- This deviceK050710 Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005
- Descendant · cites it directly · 14 of its ownK093723 Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010
- Descendant · 2 generations on · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 3 generations on · 4 of its ownK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK132478 Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014
- Descendant · 4 generations on · 2 of its ownK151912 AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K093723Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010 · cites it directly14descendants
- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · 2 generations on13descendants
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · 3 generations on4descendants
- K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014 · 3 generations on3descendants
- K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −1 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| 0 (this device) | K050710 | Minimaster Ultrasonic Scaler | E.M.S Electro Medical Systems S.A | 2005 | — |
| +1 | K093723 | Ems Minimaster Led | E.M.S Electro Medical Systems S.A | 2010 | — |
| +2 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +3 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | 3 |
| +3 | K132478 | Air-Flow Handy 3.0 | E.M.S Electro Medical Systems S.A | 2014 | — |
| +4 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 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? (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 |
|---|---|---|---|
| * | K992504 | Ems KermitSummary page 1…Master Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler 3. PREDICATE DEVICES EMS Kermit (K992504) 4. INTENDED USE * Removing supra and subgingival calculus deposits and stains from the teeth * Periodon… | 2000 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K093723 (E.M.S Electro Medical Systems S.A, 2010) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K992504.
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 | — |
What is it indicated for?
The miniMaster is an ultrasonic scaler that is intended for the following:
* Removing supra and subgingival calculus deposits and stains from the teeth
* Periodontal pocket lavage with simultaneous ultrasonic tip movement
* Scaling and root planing
* Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
* Plugging for amalgam condensation
* Amalgam burnishing
* Preparing, cleaning, and irrigating root canals
* Preparing approximal cavities
* Cementing inlays and onlays
* Retrograde preparation of root canals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050710: Minimaster Ultrasonic Scaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050710
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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