510(k) · Cleared
ClearedPiezon 250
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 Dec 6, 2013 as substantially equivalent to K953026 (Electro Medical Systems SA, 1995) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 6, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953026 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK953026 MinipiezonElectro Medical Systems SA · 1995
- This deviceK132445 Piezon 250E.M.S Electro Medical Systems S.A · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953026 | Minipiezon | Electro Medical Systems SA | 1995 | — |
| 0 (this device) | K132445 | Piezon 250 | E.M.S Electro Medical Systems S.A | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K953026 | MinipiezonSummary page 1…ic Scaler (21 CFR 872.4850, Product Code ELC) 3. PREDICATE DEVICES The proposed PIEZON 250 is a modification of the E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniPiezon (K953026). The Piezon handpiece LED that is compatible with the proposed device was described in the 510(k) premarket notification fo… | 1995 |
| * | K093000 | Ems Piezon Master 700Summary page 1…Piezon (K953026). The Piezon handpiece LED that is compatible with the proposed device was described in the 510(k) premarket notification for the Piezon Master 700 (K093000). The instruments used with the PIEZON 250 were previously cleared for E.M.S.ELECTRO MEDICAL SYSTEMS… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K953026.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
* Periodontal pocket lavage with simultaneous ultrasonic tip movement
* Scaling and root planing
* Removal of supra and subgingival calculus and stains from teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132445: Piezon 250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132445
Report an extraction error
Are you the manufacturer?
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