510(k) · Cleared
ClearedSirona 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 Dec 11, 1998 as substantially equivalent to K962071 (Pelton & Crane Co., 1996) after an 86-day review. Its family tree reaches back 1 generation to 1996. 32 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 86 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962071 (1996). 32 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- This deviceK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- Descendant · cites it directly · 20 of its ownK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- Descendant · cites it directly · 8 of its ownK152830 K3Osstem Implant Co., Ltd. · 2017
- Descendant · 2 generations on · 7 of its ownK183347 K3Osstem Implant Co., Ltd. · 2019
- Descendant · 2 generations on · 7 of its ownK080438 Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008
- Descendant · 2 generations on · 4 of its ownK151045 TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K032543Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003 · cites it directly20descendants
- K152830K3Osstem Implant Co., Ltd. · 2017 · cites it directly8descendants
- K183347K3Osstem Implant Co., Ltd. · 2019 · 2 generations on7descendants
- K080438Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008 · 2 generations on7descendants
- K151045TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| 0 (this device) | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| +1 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| +1 | K152830 | K3 | Osstem Implant Co., Ltd. | 2017 | — |
| +2 | K183347 | K3 | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
| +2 | K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K962071 | Spirit S1/S2Summary page 1…y Name: Sirona C8 Common/Usual Name: Dental Operative Unit Classification Name: Dental Operative Unit with Accessories 3. PREDICATE DEVICES Pelton & Crane’s Spirit S1 - K962071 4. DEVICE DESCRIPTION The Sirona C8 Dental Operative Unit and Accessories consist of the following components: - Treatment Cha… | 1996 |
What descends from it? (32)
See all 325 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?
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?
This product is a Dental Operative Unit with accessories that 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 Ly trained dentists ancl/ or dental technicians and assistants.
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/K983242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983242: Sirona C8 Dental Operative Unit with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983242
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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