510(k) · Cleared
ClearedCompact Piezo P2K, Powercare
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 Jan 24, 2011 as substantially equivalent to K091227 (Piezosurgery S.R.L., 2009) and 1 other predicate after a 171-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Jan 24, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K896749 (1990). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 4 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 3 generations backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- 2 generations backK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
- 1 generation backK091227 Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
- This deviceK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- Descendant · cites it directly · 2 of its ownK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
- Descendant · 2 generations on · 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −4 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −3 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| −2 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
| −1 | K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.R.L. | 2009 | — |
| 0 (this device) | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| +1 | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K091227 | Piezosurgery 3; Osstem PiezoSummary page 1…ssification Regulation: 21 CFR 872.4850: Ultrasonic scaler Predicate devices: Piezosurgery 3 (K091227) and SP Newtmon Module (K033764) 510 (k) Summary… | 2009 |
| * | K033764 | SP Newtron ModuleSummary page 1…21 CFR 872.4850: Ultrasonic scaler Predicate devices: Piezosurgery 3 (K091227) and SP Newtmon Module (K033764) 510 (k) Summary Page 1 o… | 2004 |
What descends from it? (3)
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 21 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K140965 (Mectron S.P.A., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K091227.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: All general procedures for removal of supragingival 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…
Read the full statement (85 words)
The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications:
Scaling:
All general procedures for removal of supragingival 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:
Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102218: Compact Piezo P2K, Powercare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102218
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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