510(k) · Cleared
ClearedAjax Dental Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro Dental Services, LLC · EIA Unit, Operative Dental
Cleared on Sep 5, 2014 as substantially equivalent to K102234 (A-Dec, Inc., 2010) and 1 other predicate after a 414-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Sep 5, 2014
- Review
- 414 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962071 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 backK080438 Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008
- This deviceK132245 Ajax Dental UnitPro Dental Services, LLC · 2014
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 | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
| 0 (this device) | K132245 | Ajax Dental Unit | Pro Dental Services, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K102234 | A-Dec 200 Dental SystemSummary page 4…@ajaxdent.com Contact: Kent Zhao Ajax Dental Unit — AJ1X Dental Unit with Chair EIA, Dental operative unit and accessories, 21 CFR 872.6640 1. A-DEC 200 Dental System, K102234, Manufactured by A-DEC, Inc. 2. Dental Unit with Chair, K080438, Manufactured by North West Medical Instrument (Group) Co., Ltd… | 2010 |
| * | K080438 | Dental Unit with ChairSummary page 4…nit with Chair EIA, Dental operative unit and accessories, 21 CFR 872.6640 1. A-DEC 200 Dental System, K102234, Manufactured by A-DEC, Inc. 2. Dental Unit with Chair, K080438, Manufactured by North West Medical Instrument (Group) Co., Ltd. Ajax Dental Unit AJ1X is a dental operative unit attached to a… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K102234.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 chair is used so that the patient at the dentist office may sit on it while the dentist is performing diagnosis, treatment, and/or operation. The dental unit consists of patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
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/K132245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132245: Ajax Dental Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132245
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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