510(k) · Cleared
ClearedEms Minimaster Led
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 Sep 8, 2010 as substantially equivalent to K050710 (E.M.S Electro Medical Systems S.A, 2005) and 1 other predicate after a 279-day review. Its family tree reaches back 3 generations to 1990. 14 later devices descend from it.
- Decided
- Sep 8, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896749 (1990). 6 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 2 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 1 generation backK050710 Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005
- This deviceK093723 Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010
- Descendant · cites it directly · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 2 generations on · 4 of its ownK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK132478 Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014
- Descendant · 3 generations on · 2 of its ownK151912 AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016
- Descendant · 3 generations on · 1 of its ownK231391 Combi TouchMectron S.P.A. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · cites it directly13descendants
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · 2 generations on4descendants
- K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014 · 2 generations on3descendants
- K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016 · 3 generations on2descendants
- K231391Combi TouchMectron S.P.A. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −2 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −1 | K050710 | Minimaster Ultrasonic Scaler | E.M.S Electro Medical Systems S.A | 2005 | — |
| 0 (this device) | K093723 | Ems Minimaster Led | E.M.S Electro Medical Systems S.A | 2010 | — |
| +1 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +2 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | 3 |
| +2 | K132478 | Air-Flow Handy 3.0 | E.M.S Electro Medical Systems S.A | 2014 | — |
| +3 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016 | — |
| +3 | K231391 | Combi Touch | Mectron S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K050710 | Minimaster Ultrasonic ScalerSummary page 1…trasonic Scaler Classification Name: Ultrasonic Scaler (21 CFR 872.4850, Product Code ELC) 3. PREDICATE DEVICES * miniMaster Ultrasonic Scaler (K050710) * Piezon Master 700 (K093000) 4. INTENDED USE * Removing supra and subgingival calculus deposits and stains from th… | 2005 |
| * | K093000 | Ems Piezon Master 700 Cleared while this submission was under review Summary page 1…ame: Ultrasonic Scaler (21 CFR 872.4850, Product Code ELC) 3. PREDICATE DEVICES * miniMaster Ultrasonic Scaler (K050710) * Piezon Master 700 (K093000) 4. INTENDED USE * Removing supra and subgingival calculus deposits and stains from the teeth * Periodontal pocket l… | 2010 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110173 | Ems Air-Flow Master Piezon | 2011 | 13 |
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 20 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110173 (E.M.S Electro Medical Systems S.A, 2011) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K050710.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 LED 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 planning
* 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/K093723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093723: Ems Minimaster Led.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093723
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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