510(k) · Cleared
ClearedTENEO Dental Treatment Unit and 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 Jul 24, 2015 as substantially equivalent to K032543 (Sirona Dental Systems GmbH, 2003) and 1 other predicate after a 95-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Jul 24, 2015
- Review
- 95 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962071 (1996). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 2 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 1 generation backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- This deviceK151045 TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015
- Descendant · cites it directly · 1 of its ownK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK161488 ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH · 2016
- Descendant · cites it directly · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK171872 P50 Series Dental Operative Unit and AccessoriesPelton & Crane · 2018
Most influential descendants
Showing 4 of 4 · See all- K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024 · cites it directly1descendant
- K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH · 2016 · cites it directly1descendant
- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · cites it directly0descendants
- K171872P50 Series Dental Operative Unit and AccessoriesPelton & Crane · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015 | — |
| +1 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +1 | K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | 2016 | — |
| +1 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
| +2 | K171872 | P50 Series Dental Operative Unit and Accessories | Pelton & Crane | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K032543 | Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSummary page 4…mber : 21 CFR 872.6640 Product Code : EIA, EBW Device Class :1 3 PREDICATE DEVICES C8+ DENTAL OPERATIVE UNIT WITH ACCESSORIES - (K032543) Product Code – EIA Regulation Number 21 CFR 872.6640 A-DEC 200 DENTAL SYSTEM - (K102234) Pro… | 2003 |
| * | K102234 | A-Dec 200 Dental SystemSummary page 4… C8+ DENTAL OPERATIVE UNIT WITH ACCESSORIES - (K032543) Product Code – EIA Regulation Number 21 CFR 872.6640 A-DEC 200 DENTAL SYSTEM - (K102234) Product Code – EIA Regulation Number 21 CFR 872.6640 Sirona’s C8+ is the primary predicate device for substan… | 2010 |
What descends from it? (4)
3 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 19 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K233865 (Dentsply Sirona, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K032543.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The dental treatment 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 dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes.
The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151045: TENEO Dental Treatment Unit and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151045
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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