510(k) · Cleared
ClearedEms Piezon Master 600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Medical Systems SA · ELC Scaler, Ultrasonic
Cleared on Aug 13, 2002 as substantially equivalent to K896749 (Electro Medical Systems (Ems Sa), 1990) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1990. 12 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896749 (1990). 4 ancestors in all. 12 later devices descend from it, 5 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 deviceK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- Descendant · cites it directly · 6 of its ownK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
- Descendant · 2 generations on · 5 of its ownK091227 Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
- Descendant · 3 generations on · 3 of its ownK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- Descendant · cites it directly · 2 of its ownK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
- Descendant · cites it directly · 1 of its ownK060171 Cleanse S+ Ultrasonic ScalerDmetec.Co., Ltd. · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K052518PiezosurgeryPiezosurgery S.R.L. · 2005 · cites it directly6descendants
- K091227Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009 · 2 generations on5descendants
- K102218Compact Piezo P2K, PowercareMectron S.P.A. · 2011 · 3 generations on3descendants
- K140965Multipiezo Pro, MultipiezoMectron S.P.A. · 2014 · cites it directly2descendants
- K060171Cleanse S+ Ultrasonic ScalerDmetec.Co., Ltd. · 2006 · cites it directly1descendant
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) | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| +1 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
| +2 | K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.R.L. | 2009 | — |
| +3 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| +1 | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
| +1 | K060171 | Cleanse S+ Ultrasonic Scaler | Dmetec.Co., Ltd. | 2006 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K896749 | Piezon Master 400Summary page 1…ezon@Master 600 Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler 3. Predicate Devices Piezon Master 400 (K896749) EMS KERMIT@(K992504) Electro Medical Systems SA Special 5 1O ( k ) July 17,2002 EMS Piezon@Master 600… | 1990 |
| * | K992504 | Ems KermitSummary page 1…Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler 3. Predicate Devices Piezon Master 400 (K896749) EMS KERMIT@(K992504) Electro Medical Systems SA Special 5 1O ( k ) July 17,2002 EMS Piezon@Master 600… | 2000 |
What descends from it? (12)
See all 125 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 12 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, K052518 (Piezosurgery S.R.L., 2005) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K896749.
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 PiezonmMaster 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:
Removing supra and subgingival calculus deposits and stains from 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
Cavity preparation
Cementing inlays and onlays
Retrograde preparation of root canals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022328: Ems Piezon Master 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022328
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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