510(k) · Cleared
ClearedMultipiezo Pro, Multipiezo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mectron S.P.A. · ELC Scaler, Ultrasonic
Cleared on Aug 20, 2014 as substantially equivalent to K022328 (Electro Medical Systems SA, 2002) and 1 other predicate after a 127-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 20, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896749 (1990). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 5 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 4 generations backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- 3 generations backK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
- 2 generations backK091227 Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
- 1 generation backK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- This deviceK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
- Descendant · cites it directly · 0 of its ownK223173 Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH · 2023
- Descendant · cites it directly · 0 of its ownK151023 Compact Piezo LedMectron S.P.A. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −5 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −4 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| −3 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
| −2 | K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.R.L. | 2009 | — |
| −1 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| 0 (this device) | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
| +1 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | 2023 | — |
| +1 | K151023 | Compact Piezo Led | Mectron S.P.A. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K022328 | Ems Piezon Master 600Summary page 6…quivalence of the subject devices is based on the following predicate devices: EMS Piezon Master 600, manufactured by Electro Medical System SA, 510(k) reference K022328, cleared on 13 August 2002. Compact Piezo P2K, manufactured by Mectron Spa, 510(k) reference K102218, cleared on 24… | 2002 |
| * | K102218 | Compact Piezo P2K, PowercareSummary page 6…actured by Electro Medical System SA, 510(k) reference K022328, cleared on 13 August 2002. Compact Piezo P2K, manufactured by Mectron Spa, 510(k) reference K102218, cleared on 24 January 2011. The technological characteristics and operating parameters of the Multipiezo Pro and Multipi… | 2011 |
What descends from it? (2)
2 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 24 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K223173 (W&H Dentalwerk Buermoss GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022328.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Multipiezo Pro and Multipiezo are piezoelectric ultrasonic dental scalers intended for use, with the appropriate associated tip inserts, in the following dental applications: Scaling: All general procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits; Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; Endodontics: All…
Read the full statement (91 words)
The Multipiezo Pro and Multipiezo are piezoelectric ultrasonic dental scalers intended for use, with the appropriate associated tip inserts, in the following dental applications:
Scaling: All general procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits;
Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation;
Restorative and Prosthetics: All general restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation, implants/restorations cleaning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140965: Multipiezo Pro, Multipiezo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140965
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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