510(k) · Cleared
ClearedEms Kermit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
(Ems Sa) Electro Medical Systems · ELC Scaler, Ultrasonic
Cleared on Jan 27, 2000 as substantially equivalent to K953026 (Electro Medical Systems SA, 1995) and 2 other predicates after a 184-day review. Its family tree reaches back 1 generation to 1990. 30 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 184 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K896749 (1990). 3 ancestors in all. 30 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- This deviceK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- Descendant · cites it directly · 17 of its ownK050710 Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005
- Descendant · 2 generations on · 14 of its ownK093723 Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010
- Descendant · 3 generations on · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · cites it directly · 12 of its ownK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- Descendant · 2 generations on · 6 of its ownK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K050710Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005 · cites it directly17descendants
- K093723Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010 · 2 generations on14descendants
- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · 3 generations on13descendants
- K022328Ems Piezon Master 600Electro Medical Systems SA · 2002 · cites it directly12descendants
- K052518PiezosurgeryPiezosurgery S.R.L. · 2005 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| 0 (this device) | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| +1 | K050710 | Minimaster Ultrasonic Scaler | E.M.S Electro Medical Systems S.A | 2005 | — |
| +2 | K093723 | Ems Minimaster Led | E.M.S Electro Medical Systems S.A | 2010 | — |
| +3 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +1 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| +2 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
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 |
|---|---|---|
| 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), 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? (5)
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 |
|---|---|---|---|
| * | K953026 | MinipiezonSummary page 1…17, 1999 2. DEVICE NAME Proprietary Name: EMS KERMIT® Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler 3. PREDICATE DEVICES EMS miniPiezon K953026 Piezon Master 400 K896749 KiS Microsurgical Instruments Sonicsys Amdent® US30 K920328 4. INTENDED USE e removing supra and s… | 1995 |
| * | K896749 | Piezon Master 400Summary page 1…roprietary Name: EMS KERMIT® Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler 3. PREDICATE DEVICES EMS miniPiezon K953026 Piezon Master 400 K896749 KiS Microsurgical Instruments Sonicsys Amdent® US30 K920328 4. INTENDED USE e removing supra and subgingival calculus and sta… | 1990 |
| * | K920328 | Amdent 2030, Polisher/ScalerSummary page 1…er Classification Name: Ultrasonic Scaler 3. PREDICATE DEVICES EMS miniPiezon K953026 Piezon Master 400 K896749 KiS Microsurgical Instruments Sonicsys Amdent® US30 K920328 4. INTENDED USE e removing supra and subgingival calculus and stains e periodontal pocket lavage with simultaneous ultrasonic t… | 1993 |
| * | — | KiS Microsurgical Instruments Named without a submission number | |
| * | — | Sonicsys Named without a submission number |
What descends from it? (30)
See all 303 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?
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 EMS KERMIT® is an ultrasonic scaler which 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992504: Ems Kermit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992504
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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