510(k) · Cleared
ClearedF1 Series Dental Chairs with Operative Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Fimet Medical Instrument Co., Ltd. · EIA Unit, Operative Dental
Cleared on Nov 1, 2005 as substantially equivalent to K032543 (Sirona Dental Systems GmbH, 2003) after a 54-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Nov 1, 2005
- Review
- 54 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962071 (1996). 3 later devices descend from it, 2 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 deviceK052470 F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK071353 Foshion Chair Mounted Dental, Model FJ48CShanghai Foshion Medical Instruments Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK151987 DCI Edge Dental Chair with Operative UnitDci · 2016
- Descendant · cites it directly · 0 of its ownK063302 Sdif Dental Chair with Operative Unit and AccessoriesShanghai Dental Instrument Factory · 2006
Most influential descendants
Showing 3 of 3 · See all- K071353Foshion Chair Mounted Dental, Model FJ48CShanghai Foshion Medical Instruments Co., Ltd. · 2007 · cites it directly1descendant
- K151987DCI Edge Dental Chair with Operative UnitDci · 2016 · 2 generations on0descendants
- K063302Sdif Dental Chair with Operative Unit and AccessoriesShanghai Dental Instrument Factory · 2006 · cites it directly0descendants
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) | K052470 | F1 Series Dental Chairs with Operative Unit | Shanghai Fimet Medical Instrument Co., Ltd. | 2005 | — |
| +1 | K071353 | Foshion Chair Mounted Dental, Model FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | 2007 | — |
| +2 | K151987 | DCI Edge Dental Chair with Operative Unit | Dci | 2016 | — |
| +1 | K063302 | Sdif Dental Chair with Operative Unit and Accessories | Shanghai Dental Instrument Factory | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K032543 | Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSummary page 1…nit, operative dental Product Code EIA Common/Usual Name: Dental operative unit and accessories 2. Equivalent legally marketed device: Sirona Dental Systems C8+X, K032543 3. Indications for Use (intended use): The FI Series Dental Chairs with Operative Unit is intended to supply power to and ser… | 2003 |
What descends from it? (3)
2 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 9 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071353 (Shanghai Foshion Medical Instruments Co., Ltd., 2007) has gone furthest, with 1 descendant 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.
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 FI Series Dental Chairs with Operative Unit is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052470: F1 Series Dental Chairs with Operative Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052470
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