510(k) · Cleared
ClearedElevance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midmark · EIA Unit, Operative Dental
Cleared on Aug 24, 2012 as substantially equivalent to K003090 (Midmark Corp., 2000) after a 211-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Aug 24, 2012
- Review
- 211 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003090 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003090 Midmark Procenter Instrument Delivery SystemMidmark Corp. · 2000
- This deviceK120239 ElevanceMidmark · 2012
- Descendant · cites it directly · 2 of its ownK143696 SpiritPelton & Crane · 2015
- Descendant · 2 generations on · 1 of its ownK173608 Forest Dental UnitForest Dental Products, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK251626 Midmark Dental Delivery SystemMidmark Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK231297 Firstar Dental UnitFirstar Dental Company · 2025
Most influential descendants
Showing 4 of 4 · See all- K143696SpiritPelton & Crane · 2015 · cites it directly2descendants
- K173608Forest Dental UnitForest Dental Products, Inc. · 2018 · 2 generations on1descendant
- K251626Midmark Dental Delivery SystemMidmark Corporation · 2025 · cites it directly0descendants
- K231297Firstar Dental UnitFirstar Dental Company · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003090 | Midmark Procenter Instrument Delivery System | Midmark Corp. | 2000 | — |
| 0 (this device) | K120239 | Elevance | Midmark | 2012 | — |
| +1 | K143696 | Spirit | Pelton & Crane | 2015 | — |
| +2 | K173608 | Forest Dental Unit | Forest Dental Products, Inc. | 2018 | — |
| +1 | K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025 | — |
| +3 | K231297 | Firstar Dental Unit | Firstar Dental Company | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003090 | Midmark Procenter Instrument Delivery SystemSummary page 1…Product Code EIA Unmodified Device Midmark Procenter Instrument Delivery System K003090 Description The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpie… | 2000 |
What descends from it? (4)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K143696 (Pelton & Crane, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120239: Elevance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120239
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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