510(k) · Cleared
ClearedSpirit S1/S2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelton & Crane Co. · EIA Unit, Operative Dental
Cleared on Aug 6, 1996 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 35 later devices descend from it.
- Decided
- Aug 6, 1996
- Review
- 70 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 5 citing it directly.
- This deviceK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- Descendant · cites it directly · 32 of its ownK983242 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 · 2 generations on · 8 of its ownK152830 K3Osstem Implant Co., Ltd. · 2017
- Descendant · 3 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
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K983242Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998 · cites it directly32descendants
- K032543Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003 · cites it directly20descendants
- K152830K3Osstem Implant Co., Ltd. · 2017 · 2 generations on8descendants
- K183347K3Osstem Implant Co., Ltd. · 2019 · 3 generations on7descendants
- K080438Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| +1 | 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 | — |
| +2 | K152830 | K3 | Osstem Implant Co., Ltd. | 2017 | — |
| +3 | K183347 | K3 | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 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 | 2 | 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (35)
See all 355 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?
- Of its descendants, K983242 (Sirona Dental Systems GmbH, 1998) has gone furthest, with 32 descendants of its own.
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 | — |
https://510kreport.com/device/K962071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962071: Spirit S1/S2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962071
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026