FDA product code KLC: Chair, Dental, With Operative Unit
KLC is the FDA product code for chair, dental, with operative unit. It is a Class I device, regulated under 21 CFR 872.6250 and reviewed by the Dental panel. FDA has cleared 63 510(k) submissions under KLC, 1 in the last five years, from 31 different applicants. The average 510(k) review took 179 days (median 85); 268 days on average over the last three years. FDA has posted 7 recalls for KLC devices.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Dental, With Operative Unit |
| Device class | Class I |
| Regulation | 21 CFR 872.6250 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KLC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 268 |
Compare with all 510(k) review times · Search every KLC clearance
Top KLC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A-Dec, Inc. | 18 | 1994-01-31 |
| Oriola OY Finndent | 7 | 1990-02-14 |
| Alpine Dental Equipment Co. | 4 | 1988-09-23 |
| Planmeca USA, Inc. | 2 | 1994-01-31 |
| Healthpak, Inc. | 2 | 1992-08-06 |
26 more applicants have KLC clearances. See the full list in Caduvo.
Most recent KLC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233921 | Dentis Co., Ltd. | Luvis Chair (LC700C) | 2024-09-06 | 268 |
| K151987 | Dci | DCI Edge Dental Chair with Operative Unit | 2016-06-01 | 320 |
| K071353 | Shanghai Foshion Medical Instruments Co., Ltd. | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | 2007-12-14 | 213 |
| K971063 | King Dental Corp. | OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR | 1997-06-03 | 71 |
| K963209 | Planmeca Oy | PROSTYLE COMPACT | 1996-10-24 | 69 |
Recalls for KLC devices
7 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-02-24.
Frequently asked questions
What is FDA product code KLC?
KLC is the FDA product code for chair, dental, with operative unit. It is a Class I device, regulated under 21 CFR 872.6250 and reviewed by the Dental panel.
What device class is KLC?
Class I, regulation 21 CFR 872.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLC?
Across 63 cleared submissions the average was 179 days from receipt to decision (median 85).
Which companies have the most KLC clearances?
A-Dec, Inc. (18); Oriola OY Finndent (7); Alpine Dental Equipment Co. (4); Planmeca USA, Inc. (2); Healthpak, Inc. (2).
Have KLC devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2010-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code KLC
- Run a recall and safety report across every KLC manufacturer
- Watch product code KLC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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