510(k) · Cleared
ClearedESTETICA Dental Treatment Unit and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH · EIA Unit, Operative Dental
Cleared on Dec 8, 2016 as substantially equivalent to K151045 (Sirona Dental Systems GmbH, 2015) after a 190-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Dec 8, 2016
- Review
- 190 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962071 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 3 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 2 generations backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- 1 generation backK151045 TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015
- This deviceK161488 ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH · 2016
- Descendant · cites it directly · 0 of its ownK171872 P50 Series Dental Operative Unit and AccessoriesPelton & Crane · 2018
Most influential descendants
Showing 1 of 1 · See all- K171872P50 Series Dental Operative Unit and AccessoriesPelton & Crane · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −3 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −2 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| −1 | K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015 | — |
| 0 (this device) | K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | 2016 | — |
| +1 | 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 |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K151045 | TENEO Dental Treatment Unit and AccessoriesSummary page 4…ass I Product Code - EIA Devices for Which Substantial Equivalence is claimed: TENEO Dental Treatment Unit and Accessories marketed by Sirona Dental Systems GmbH (K151045). Trade Name - TENEO Dental Treatment Unit and Accessories Common Name - Unit, Operative Dental Classification Name -… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171872 | P50 Series Dental Operative Unit and Accessories | 2018 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171872 (Pelton & Crane, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K151045.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.
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/K161488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161488: ESTETICA 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/K161488
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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