510(k) · Cleared
ClearedMaxima Electric System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handpiece Headquarters - Hpr, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on Jul 25, 2019 as substantially equivalent to K103027 (Kaltenbach & Voigt GmbH, 2011) after a 479-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jul 25, 2019
- Review
- 479 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K964860 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- 4 generations backK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- 3 generations backK042759 Optima MXBien-Air SA Switzerland · 2004
- 2 generations backK080677 Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008
- 1 generation backK103027 Electrotorque TLCKaltenbach & Voigt GmbH · 2011
- This deviceK180845 Maxima Electric SystemHandpiece Headquarters - Hpr, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| −4 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| −3 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| −2 | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| −1 | K103027 | Electrotorque TLC | Kaltenbach & Voigt GmbH | 2011 | — |
| 0 (this device) | K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 EBW? 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 EBW device
- #1 K251701 Star E900 Electric Systemscore 12.2 · 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 |
|---|---|---|---|
| * | K103027 | Electrotorque TLCSummary page 4…e: EBW Class: I e- Substantial Equivalency is claimed against the following device: ELECTROtorque TLC4893 with INTRAmatic KL 702 by Kaltenbach & Voight GmnbH 510(k) # K103027 f- Indications for Use The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to ele… | 2011 |
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 22 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K103027.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 2025
MAUDE reports naming product code EBW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 112 | 0 | 16 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 3 | 226 | 0 | 1 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 3 | 189 | 0 | 4 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 4 | 227 | 0 | 13 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 2 | — | 0 | 55 |
| 2020 | 1 | — | 0 | 71 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 6 | 479 | 0 | 31 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 4 | 268 | 0 | 14 |
| 2025 | 3 | 220 | 0 | 13 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. This system is designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180845: Maxima Electric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180845
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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