510(k) · Cleared
ClearedEms Piezon 707 Bik and Piezon 707 Bik Led
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 Feb 27, 2015 as substantially equivalent to K033764 (Satelec, 2004) after a 316-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 27, 2015
- Review
- 316 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942139 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK942139 Suprasson P MaxSatelec · 1995
- 3 generations backK961158 Suprasson P5 BoosterSatelec · 1996
- 2 generations backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- 1 generation backK033764 SP Newtron ModuleSatelec · 2004
- This deviceK140990 Ems Piezon 707 Bik and Piezon 707 Bik LedE.M.S Electro Medical Systems S.A · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −3 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| −2 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| −1 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| 0 (this device) | K140990 | Ems Piezon 707 Bik and Piezon 707 Bik Led | E.M.S Electro Medical Systems S.A | 2015 | — |
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? (1)
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 |
|---|---|---|---|
| * | K033764 | SP Newtron ModuleSummary page 4…ode ELC) 3. PREDICATE DEVICES The PIEZON® 707 BIK and PIEZON® BIK LED is substantially equivalent to the Satelec SP Newtron Module, cleared for marketing in K033764. The Piezon Handpiece and Piezon Handpiece LED that are supplied with the proposed device were described in the 510(k)… | 2004 |
| † | K132443 | Piezon 150 | 2013 |
| † | K132445 | Piezon 250 | 2013 |
| † | K093000 | Ems Piezon Master 700 | 2010 |
| † | K050710 | Minimaster Ultrasonic Scaler | 2005 |
| † | K992504 | Ems Kermit | 2000 |
| † | K953026 | Minipiezon | 1995 |
| † | K896749 | Piezon Master 400 | 1990 |
| † | K022328 | Ems Piezon Master 600 | 2002 |
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K033764.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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® 707 BIK and PIEZON® BIK LED is intended for use for the following indications:
Scaling
• Removal of supragingival calculus
• Removal of stains
Endo
• Preparation, cleaning and irrigation of root canals
• Condensing gutta-percha
• Removal of crowns, bridges and restorations
Restorative
• Preparation of cavities
• Cementation of restorations
• Condensing of amalgams
Periodontics
• Scaling and root planing
• Periodontal therapy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140990: Ems Piezon 707 Bik and Piezon 707 Bik Led.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140990
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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