510(k) · Cleared
ClearedOptima Plus E Dental Chair; a Dental Chair; Excel Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
King Dental Corp. · KLC Chair, Dental, With Operative Unit
Cleared on Jun 3, 1997 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 3, 1997
- Review
- 71 days
- Class
- Class I
- Product code
- KLC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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.
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?
THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971063: Optima Plus E Dental Chair; a Dental Chair; Excel Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026