510(k) · Cleared
ClearedInfinity Pro, Logic, Quality, Sprint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olsen Indústria E Comércio S.A. · EIA Unit, Operative Dental
Cleared on Oct 19, 2022 as substantially equivalent to K180935 (Olsen Industria E Comercio S.A., 2020) after a 324-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Oct 19, 2022
- Review
- 324 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K180935 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK180935 Infinity / Infinity Cross Flex Dental SystemsOlsen Industria E Comercio S.A. · 2020
- This deviceK213742 Infinity Pro, Logic, Quality, SprintOlsen Indústria E Comércio S.A. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | 2020 | — |
| 0 (this device) | K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | 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 |
|---|---|---|---|
| * | K180935 | Infinity / Infinity Cross Flex Dental SystemsSummary page 4…ry Class: Class I Product Code: EIA Additional Product Code: EBW Classification Panel: Dental III. PREDICATE DEVICE Olsen Infinity / Infinity Cross Flex Dental System, K180935 IV. DEVICE DESCRIPTION The Olsen dental units consist of a patient chair, foot control, dentist element, assistant element, wat… | 2020 |
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?
- Its one ancestor has no recall.
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?
Infinity Pro, Logic, Quality, Sprint are 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, electricity, and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213742 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213742: Infinity Pro, Logic, Quality, Sprint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213742
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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