510(k) · Cleared
ClearedPerceptive electric dental motor and control unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lares Research · EIA Unit, Operative Dental
Cleared on Dec 15, 2022 as substantially equivalent to K042759 (Bien-Air SA Switzerland, 2004) after a 265-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 15, 2022
- Review
- 265 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964860 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK964860 Mark 20 and Mark 25 Hand Engine ControllerBell Intl., Inc. · 1997
- 2 generations backK031584 Sirotorque LSirona Dental Systems GmbH · 2003
- 1 generation backK042759 Optima MXBien-Air SA Switzerland · 2004
- This deviceK220873 Perceptive electric dental motor and control unitLares Research · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964860 | Mark 20 and Mark 25 Hand Engine Controller | Bell Intl., Inc. | 1997 | — |
| −2 | K031584 | Sirotorque L | Sirona Dental Systems GmbH | 2003 | — |
| −1 | K042759 | Optima MX | Bien-Air SA Switzerland | 2004 | — |
| 0 (this device) | K220873 | Perceptive electric dental motor and control unit | Lares Research | 2022 | — |
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 |
|---|---|---|---|
| * | K042759 | Optima MXSummary page 4…807.92(a)(3) Predicate Device (primary): Bien Air Dental – Optima MCX, K042759 Device Description 807.92(a)(4) The Lares Research Perceptive electrical mot… | 2004 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K042759.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
This device is intended for use in general dentistry and restorative dentistry by dentists and dental professionals in a dental office.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220873: Perceptive electric dental motor and control unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220873
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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