510(k) · Cleared
ClearedDCI Edge Dental Chair with Operative Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dci · KLC Chair, Dental, With Operative Unit
Cleared on Jun 1, 2016 as substantially equivalent to K071353 (Shanghai Foshion Medical Instruments Co., Ltd., 2007) after a 320-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jun 1, 2016
- Review
- 320 days
- Class
- Class I
- Product code
- KLC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962071 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK962071 Spirit S1/S2Pelton & Crane Co. · 1996
- 4 generations backK983242 Sirona C8 Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 1998
- 3 generations backK032543 Sirona Dental Systems C8+Dental Operative Unit with AccessoriesSirona Dental Systems GmbH · 2003
- 2 generations backK052470 F1 Series Dental Chairs with Operative UnitShanghai Fimet Medical Instrument Co., Ltd. · 2005
- 1 generation backK071353 Foshion Chair Mounted Dental, Model FJ48CShanghai Foshion Medical Instruments Co., Ltd. · 2007
- This deviceK151987 DCI Edge Dental Chair with Operative UnitDci · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962071 | Spirit S1/S2 | Pelton & Crane Co. | 1996 | — |
| −4 | K983242 | Sirona C8 Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 1998 | — |
| −3 | K032543 | Sirona Dental Systems C8+Dental Operative Unit with Accessories | Sirona Dental Systems GmbH | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K151987 | DCI Edge Dental Chair with Operative Unit | Dci | 2016 | — |
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 |
|---|---|---|---|
| * | K071353 | Foshion Chair Mounted Dental, Model FJ48CSummary page 4…R 872.6250 Class: 1 Product Code: KLC Secondary Product Code: EIA Establishment Registration Number: 3029780 3 Predicate Device Foshion Chair Mounted Dental Unit (K071353) 4 Intended Use The DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manne… | 2007 |
| † | K944271 | Dental Operative Unit Accesories | 1994 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
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. 2016, 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 DCI Edge Dental Chair with operative unit is a device intended to position the patient in such a manner to provide to the dental practitioner visual and manual access to the oral cavity. This device should provide for the ergonomic necessities of most patients, both adults and children, throughout its range of movement. The device shall also be the means of supporting delivery systems for the purpose of standard dental procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151987: DCI Edge Dental Chair with Operative Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151987
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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