510(k) · Cleared
ClearedA-Dec 200 Dental System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Dec, Inc. · EIA Unit, Operative Dental
Cleared on Nov 24, 2010 after a 107-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Nov 24, 2010
- Review
- 107 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK102234 A-Dec 200 Dental SystemA-Dec, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK151045 TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 1 of its ownK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK161488 ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH · 2016
- Descendant · cites it directly · 1 of its ownK151996 Taurus C1Shinhung Company, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK150909 INTEGO Family and AccesoriesSirona Dental Systems GmbH · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151045TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH · 2015 · cites it directly4descendants
- K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024 · 2 generations on1descendant
- K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH · 2016 · 2 generations on1descendant
- K151996Taurus C1Shinhung Company, Ltd. · 2016 · cites it directly1descendant
- K150909INTEGO Family and AccesoriesSirona Dental Systems GmbH · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102234 | A-Dec 200 Dental System | A-Dec, Inc. | 2010 | — |
| +1 | K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +2 | K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | 2016 | — |
| +1 | K151996 | Taurus C1 | Shinhung Company, Ltd. | 2016 | — |
| +1 | K150909 | INTEGO Family and Accesories | Sirona Dental Systems GmbH | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
4 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, K151045 (Sirona Dental Systems GmbH, 2015) has gone furthest, with 4 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. 2010, 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 A-dec 200 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102234: A-Dec 200 Dental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102234
Report an extraction error
Are you the manufacturer?
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