510(k) · Cleared
ClearedOptima MX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bien-Air SA Switzerland · EIA Unit, Operative Dental
Cleared on Oct 20, 2004 as substantially equivalent to K031584 (Sirona Dental Systems GmbH, 2003) after a 15-day review. Its family tree reaches back 2 generations to 1997. 11 later devices descend from it.
- Decided
- Oct 20, 2004
- Review
- 15 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964860 (1997). 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- 1 generation backK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- This deviceK042759 Optima MXBien-Air SA Switzerland · 2004
- Descendant · cites it directly · 4 of its ownK080677 Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008
- Descendant · cites it directly · 2 of its ownK103027 Electrotorque TLCKaltenbach & Voigt GmbH · 2011
- Descendant · cites it directly · 2 of its ownK090937 E-Statis 40 SystemScican, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK201191 Elec-LedMicro-Nx Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080677Comfortronic 4894 and Comfortdrive 200XDA HandpieceKaltenbach & Voigt GmbH & Co. · 2008 · cites it directly4descendants
- K103027Electrotorque TLCKaltenbach & Voigt GmbH · 2011 · cites it directly2descendants
- K090937E-Statis 40 SystemScican, Ltd. · 2009 · cites it directly2descendants
- K201191Elec-LedMicro-Nx Co., Ltd. · 2022 · cites it directly1descendant
- K163402NLZ Motor SystemNakanishi, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| −1 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| 0 (this device) | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| +1 | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | Kaltenbach & Voigt GmbH & Co. | 2008 | — |
| +1 | K103027 | Electrotorque TLC | Kaltenbach & Voigt GmbH | 2011 | — |
| +1 | K090937 | E-Statis 40 System | Scican, Ltd. | 2009 | — |
| +1 | K201191 | Elec-Led | Micro-Nx Co., Ltd. | 2022 | — |
| +2 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 2 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 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 |
|---|---|---|---|
| * | K031584 | Sirotorque LSummary page 1…DICATE DEVICES Company Device 510(k) No. Date Cleared Sirona Dental Systems SiroTorque L K031584 08/19/2003 15.4 DEVICE DESCRIPTION The Optima MX dental unit for use in dental restoration, pbophylaxis… | 2003 |
What descends from it? (11)
See all 115 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 7 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080677 (Kaltenbach & Voigt GmbH & Co., 2008) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K031584.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Optima MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042759: Optima MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042759
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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