510(k) · Cleared
ClearedSpirit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelton & Crane · EIA Unit, Operative Dental
Cleared on Sep 18, 2015 as substantially equivalent to K120239 (Midmark, 2012) after a 268-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Sep 18, 2015
- Review
- 268 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003090 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003090 Midmark Procenter Instrument Delivery SystemMidmark Corp. · 2000
- 1 generation backK120239 ElevanceMidmark · 2012
- This deviceK143696 SpiritPelton & Crane · 2015
- Descendant · cites it directly · 1 of its ownK173608 Forest Dental UnitForest Dental Products, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK231297 Firstar Dental UnitFirstar Dental Company · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003090 | Midmark Procenter Instrument Delivery System | Midmark Corp. | 2000 | — |
| −1 | K120239 | Elevance | Midmark | 2012 | — |
| 0 (this device) | K143696 | Spirit | Pelton & Crane | 2015 | — |
| +1 | K173608 | Forest Dental Unit | Forest Dental Products, Inc. | 2018 | — |
| +2 | K231297 | Firstar Dental Unit | Firstar Dental Company | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K120239 | ElevanceSummary page 4…2.6640 Device Class: I Product Code: EIA 3. Predicate Device: Proprietary Name: ELEVANCE - (K120239) Common Name: Dental Delivery Unit Classification Name: Unit, Operative Dental… | 2012 |
| † | K103027 | Electrotorque TLC | 2011 |
| † | K080677 | Comfortronic 4894 and Comfortdrive 200XDA Handpiece | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173608 | Forest Dental Unit | 2018 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173608 (Forest Dental Products, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120239.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143696: Spirit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143696
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