510(k) · Cleared
ClearedMare Dental Operative Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denimed Electronica S.H. · EIA Unit, Operative Dental
Cleared on Aug 24, 2004 as substantially equivalent to K032543 (Sirona Dental Systems GmbH, 2003) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 24, 2004
- Review
- 84 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962071 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 2 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 1 generation backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- This deviceK041458 Mare Dental Operative UnitDenimed Electronica S.H. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −2 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −1 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| 0 (this device) | K041458 | Mare Dental Operative Unit | Denimed Electronica S.H. | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K032543 | Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSummary page 1…Dental Operative Unit III. ClassificationName: Dental Operative Unit with Accessories Predicate Devices: L C 8 i Dental Operative Unit with Accessories, K032543 11. Spirit S I Dental Operative Unit with Accessories, K962071 I === Page… | 2003 |
| * | K962071 | Spirit S1/S2Summary page 1…erative Unit with Accessories Predicate Devices: L C 8 i Dental Operative Unit with Accessories, K032543 11. Spirit S I Dental Operative Unit with Accessories, K962071 I Intended Use: The Mare Dental Operative Unit with accessorie… | 1996 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K032543.
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 Mare Dental Operative Unit and Accessories is intended for use in general dental
applications by providing the dental practitioner a user interface to control operation
of the dental chair and attached dental devices.
The system delivers air, water, and electricity to allow the dental practitioner an
intuitive control center for all common and normal patient treatment procedures
performed in the dental office.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041458: Mare Dental Operative Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041458
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