510(k) · Cleared
ClearedFoshion Chair Mounted Dental, Model FJ48C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Foshion Medical Instruments Co., Ltd. · KLC Chair, Dental, With Operative Unit
Cleared on Dec 14, 2007 as substantially equivalent to K052470 (Shanghai Fimet Medical Instrument Co., Ltd., 2005) after a 213-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Dec 14, 2007
- Review
- 213 days
- Class
- Class I
- Product code
- KLC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962071 (1996). 1 later device descends from it, 1 citing it directly.
- 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 backK052470 F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 2005
- This deviceK071353 Foshion Chair Mounted Dental, Model FJ48CShanghai Foshion Medical Instruments Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK151987 DCI Edge Dental Chair with Operative UnitDci · 2016
Most influential descendants
Showing 1 of 1 · See all- K151987DCI Edge Dental Chair with Operative UnitDci · 2016 · cites it directly0descendants
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 | K052470 | F1 Series Dental Chairs with Operative Unit | Shanghai Fimet Medical Instrument Co., Ltd. | 2005 | — |
| 0 (this device) | K071353 | Foshion Chair Mounted Dental, Model FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | 2007 | — |
| +1 | K151987 | DCI Edge Dental Chair with Operative Unit | Dci | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KLC? 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 KLC device
- #1 K233921 Luvis Chair (LC700C)score 11.9 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K052470 | F1 Series Dental Chairs with Operative UnitSummary page 1…nit. Device classification name: EIA, Dental Opernllive Unit, 21 CFR 872.6640 Legally marketed device to F1 Series Dental E:hairs with Operative Unit, K052470 Manufactured by which the device is Shanghai Fimet Neladical Instrument Co., Ltd. substantially equivalent: De… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151987 | DCI Edge Dental Chair with Operative Unit | 2016 | 0 |
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?
How does its category compare?
All KLC devicesKLC Chair, Dental, With Operative Unit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KLC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KLC
Too few KLC 510(k)s in any year since 2007 to give a median.
Recalls per year · KLC
6in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLC
1in 2022
MAUDE reports naming product code KLC, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 6 | 1 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071353: Foshion Chair Mounted Dental, Model FJ48C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071353
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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