510(k) · Cleared
ClearedSirona Dental Systems C8+Dental Operative Unit with Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EIA Unit, Operative Dental
Cleared on Nov 14, 2003 as substantially equivalent to K983242 (Sirona Dental Systems GmbH, 1998) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1996. 20 later devices descend from it.
- Decided
- Nov 14, 2003
- Review
- 88 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962071 (1996). 20 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 1 generation backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- This deviceK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- Descendant · cites it directly · 7 of its ownK080438 Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008
- Descendant · cites it directly · 4 of its ownK151045 TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 4 of its ownK130410 Dental Unit with ChairXianyang North West Medical Instrument (Group) Co. · 2013
- Descendant · 3 generations on · 3 of its ownK142206 Dental UnitZhuhai Siger Medical Equipment Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK052470 F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 2005
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K080438Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008 · cites it directly7descendants
- K151045TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015 · cites it directly4descendants
- K130410Dental Unit with ChairXianyang North West Medical Instrument (Group) Co. · 2013 · 2 generations on4descendants
- K142206Dental UnitZhuhai Siger Medical Equipment Co., Ltd. · 2015 · 3 generations on3descendants
- K052470F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 2005 · cites it directly3descendants
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) | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| +1 | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
| +1 | K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K130410 | Dental Unit with Chair | Xianyang North West Medical Instrument (Group) Co. | 2013 | — |
| +3 | K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | 2015 | — |
| +1 | K052470 | F1 Series Dental Chairs with Operative Unit | Shanghai Fimet Medical Instrument Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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…tive Unit Classification Name: Dental Operative Unit with Accessories 3. PREDICATE DEVICES C8 Dental Operative Unit with Accessories, K983242 Spirit S 1 Dental Operative Unit with Accessories, K962071 4. INTENDED USE The Cg-tDental Operative Unit with a… | 1998 |
| * | K962071 | Spirit S1/S2Summary page 1…ith Accessories 3. PREDICATE DEVICES C8 Dental Operative Unit with Accessories, K983242 Spirit S 1 Dental Operative Unit with Accessories, K962071 4. INTENDED USE The Cg-tDental Operative Unit with accessories is intended to supply power to and serve as a ba… | 1996 |
What descends from it? (20)
See all 206 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080438 (North West Medical Instrument (Group) Co., Ltd., 2008) has gone furthest, with 7 descendants of its own.
- 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 C8+ Dental Operative Unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.
The C8+ Dental Operative Unit is offered with the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032543
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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