Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6250](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6250) → KLC — Chair, Dental, With Operative Unit

# KLC · Chair, Dental, With Operative Unit

_Dental · 21 CFR 872.6250 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/KLC

## Overview

- **Product Code:** KLC
- **Device Name:** Chair, Dental, With Operative Unit
- **Regulation:** [21 CFR 872.6250](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6250)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

## Classification Rationale

Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

## Recent Cleared Devices (20 of 63)

Showing 20 most recent of 63 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233921](/device/K233921.md) | Luvis Chair (LC700C) | Dentis Co., Ltd. | Sep 6, 2024 | SESE |
| [K151987](/device/K151987.md) | DCI Edge Dental Chair with Operative Unit | Dci | Jun 1, 2016 | SESE |
| [K071353](/device/K071353.md) | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | Dec 14, 2007 | SESE |
| [K971063](/device/K971063.md) | OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR | King Dental Corp. | Jun 3, 1997 | SESE |
| [K963209](/device/K963209.md) | PROSTYLE COMPACT | Planmeca Oy | Oct 24, 1996 | SESE |
| [K942870](/device/K942870.md) | ULTIMA 2 DENTAL CHAIR | Dentech Corp. | Feb 27, 1995 | SESE |
| [K940950](/device/K940950.md) | KAVO SYSTEMATICA 1060 | Kavo America | Dec 29, 1994 | SESE |
| [K925567](/device/K925567.md) | E 4000 DENTAL OPERATING CHAIR | Dentalez Group | Mar 10, 1994 | SESE |
| [K925119](/device/K925119.md) | A-DEC 1040 CHAIR | A-Dec, Inc. | Jan 31, 1994 | SESE |
| [K923534](/device/K923534.md) | PM2002 PROLINE | Planmeca USA, Inc. | Jan 31, 1994 | SESE |
| [K925325](/device/K925325.md) | A-DEC 2185 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925324](/device/K925324.md) | A-DEC 2184 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925323](/device/K925323.md) | A-DEC 2183 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925322](/device/K925322.md) | A-DEC 2147 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925321](/device/K925321.md) | A-DEC 2146 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925320](/device/K925320.md) | A-DEC 2145 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925319](/device/K925319.md) | A-DEC 2182 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925318](/device/K925318.md) | A-DEC 2181 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925317](/device/K925317.md) | A-DEC 2180 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE |
| [K925316](/device/K925316.md) | A-DEC 2172 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |

## Top Applicants

- A-Dec, Inc. — 18 clearances
- Oriola OY Finndent — 7 clearances
- Alpine Dental Equipment Co. — 4 clearances
- Chayes Virginia, Inc. — 2 clearances
- Den-Tal-Ez Mfg Co., Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/KLC](https://fda.innolitics.com/productcode/KLC)

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