510(k) · Cleared
ClearedDental Unit with Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North West Medical Instrument (Group) Co., Ltd. · EIA Unit, Operative Dental
Cleared on Apr 4, 2008 as substantially equivalent to K032543 (Sirona Dental Systems GmbH, 2003) after a 45-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.
- Decided
- Apr 4, 2008
- Review
- 45 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962071 (1996). 7 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 deviceK080438 Dental Unit with ChairNorth West Medical Instrument (Group) Co., Ltd. · 2008
- Descendant · cites it directly · 4 of its ownK130410 Dental Unit with ChairXianyang North West Medical Instrument (Group) Co. · 2013
- Descendant · 2 generations on · 3 of its ownK142206 Dental UnitZhuhai Siger Medical Equipment Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK231845 Dental unit Model: MareFoshan Safety Medical Equipment Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK242611 Integral Dental UnitsMipont Medical Equipment Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK242646 Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130410Dental Unit with ChairXianyang North West Medical Instrument (Group) Co. · 2013 · cites it directly4descendants
- K142206Dental UnitZhuhai Siger Medical Equipment Co., Ltd. · 2015 · 2 generations on3descendants
- K231845Dental unit Model: MareFoshan Safety Medical Equipment Co., Ltd. · 2024 · 3 generations on2descendants
- K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd. · 2025 · 4 generations on0descendants
- K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd. · 2025 · 4 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) | K080438 | Dental Unit with Chair | North West Medical Instrument (Group) Co., Ltd. | 2008 | — |
| +1 | K130410 | Dental Unit with Chair | Xianyang North West Medical Instrument (Group) Co. | 2013 | — |
| +2 | K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | 2015 | — |
| +3 | K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024 | — |
| +4 | K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | 2025 | — |
| +4 | K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K032543 | Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSummary page 2…= Page 2 === Premarket Notification 510(k) Submission-5 10(k) Summary Report No.:A20071006 Email: Diana.hong~mid-link.net 3. Predicate Device K Number: K032543 C8+DENTAL OPERATIVE UNIT Classification Name: Unit, Operative Dental Product Code: EIA Manufacturer: SIRONA DENTA… | 2003 |
What descends from it? (7)
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 12 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130410 (Xianyang North West Medical Instrument (Group) Co., 2013) has gone furthest, with 4 descendants 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. 2008, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K080438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080438: Dental Unit with Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080438
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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