510(k) · Cleared
ClearedIntegral Dental Units
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mipont Medical Equipment Co., Ltd. · EIA Unit, Operative Dental
Cleared on May 27, 2025 as substantially equivalent to K231845 (Foshan Safety Medical Equipment Co., Ltd., 2024) and 1 other predicate after a 266-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- May 27, 2025
- Review
- 266 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962071 (1996). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 6 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 5 generations backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- 4 generations backK080438 Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008
- 3 generations backK130410 Dental Unit with ChairXianyang North West Medical Instrument (Group) Co. · 2013
- 2 generations backK142206 Dental UnitZhuhai Siger Medical Equipment Co., Ltd. · 2015
- 1 generation backK231845 Dental unit Model: MareFoshan Safety Medical Equipment Co., Ltd. · 2024
- This deviceK242611 Integral Dental UnitsMipont Medical Equipment Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −6 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −5 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| −4 | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
| −3 | K130410 | Dental Unit with Chair | Xianyang North West Medical Instrument (Group) Co. | 2013 | — |
| −2 | K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | 2015 | — |
| −1 | K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024 | — |
| 0 (this device) | K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K231845 | Dental unit Model: MareSummary page 6…Page 1 Regulation Number: 872.6640 Class: Class I Review Panel: Dental 5. Predicate Device 1 Information: 510(k) Number: K231845 Device Classification Name: Dental operative unit and accessories Sponsor: Foshan Safety Medical Equipment Co., Ltd… | 2024 |
| * | K233921 | Luvis Chair (LC700C) Cleared while this submission was under review Summary page 6…6640 Class: Class I Review Panel: Dental Trade/Proprietary Name: Dental Unit, model: Mare 6. Predicate Device 2 Information: 510(k) Number: K233921 Device Classification Name: Dental operative unit and accessories Sponsor: DENTIS CO., LTD. Classification P… | 2024 |
| † | K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L | 2006 |
| † | K243921 | LED Curing Lights (DB686 HALO) | 2025 |
| † | K170229 | Dental High-speed Turbine Handpiece | 2017 |
| † | K170236 | Dental Low-speed Turbine Handpiece | 2017 |
| † | K203706 | Dental Electric Motor | 2022 |
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 29 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K231845.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Unit 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 as stated in the FDA summary.
https://510kreport.com/device/K242611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242611: Integral Dental Units.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242611
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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