510(k) · Cleared
ClearedSpaceline Emcia, Model CU580
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EIA Unit, Operative Dental
Cleared on Feb 16, 2005 as substantially equivalent to K983242 (Sirona Dental Systems GmbH, 1998) and 1 other predicate after a 61-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 16, 2005
- Review
- 61 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962071 (1996). 3 ancestors in all, the oldest K953865 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −1 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| 0 (this device) | K043496 | Spaceline Emcia, Model CU580 | J. Morita USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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 |
|---|---|---|---|
| * | K983242 | Sirona C8 Dental Operative Unit with AccessoriesSummary page 1…ETA 5. Substantial Equivalency is claimed against the following device: SIRONA C8 from Sirona Dental Systems, GmgH. 510k# K983242 1/2 6. Description of the device:… | 1998 |
| * | K953865 | Spaceline Feel 21Summary page 2…he CU 580 is substantially equivalent to both the Spaceline Feel from SIRONA Dental LMORITA, MFG. CORP. (K#953865) and the Sirona C8 intended uses, Systems GmbH (K#983242)..be… | 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 9 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K983242.
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 CU580 is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the chair and attached dental devices. It delivers air, water, vacuum, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.
It is for use by authorized persons in the practice of dentistry, prosthodontites, oral surgery, orthodontics, and oral hygeine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043496: Spaceline Emcia, Model CU580.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043496
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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