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/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/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](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K233921.md) | Luvis Chair (LC700C) | Dentis Co., Ltd. | Sep 6, 2024 | SESE | | [K151987](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K151987.md) | DCI Edge Dental Chair with Operative Unit | Dci | Jun 1, 2016 | SESE | | [K071353](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K071353.md) | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | Dec 14, 2007 | SESE | | [K971063](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K971063.md) | OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR | King Dental Corp. | Jun 3, 1997 | SESE | | [K963209](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K963209.md) | PROSTYLE COMPACT | Planmeca Oy | Oct 24, 1996 | SESE | | [K942870](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K942870.md) | ULTIMA 2 DENTAL CHAIR | Dentech Corp. | Feb 27, 1995 | SESE | | [K940950](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K940950.md) | KAVO SYSTEMATICA 1060 | Kavo America | Dec 29, 1994 | SESE | | [K925567](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925567.md) | E 4000 DENTAL OPERATING CHAIR | Dentalez Group | Mar 10, 1994 | SESE | | [K925119](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925119.md) | A-DEC 1040 CHAIR | A-Dec, Inc. | Jan 31, 1994 | SESE | | [K923534](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K923534.md) | PM2002 PROLINE | Planmeca USA, Inc. | Jan 31, 1994 | SESE | | [K925325](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925325.md) | A-DEC 2185 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925324](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925324.md) | A-DEC 2184 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925323](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925323.md) | A-DEC 2183 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925322](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925322.md) | A-DEC 2147 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925321](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925321.md) | A-DEC 2146 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925320](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925320.md) | A-DEC 2145 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925319](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925319.md) | A-DEC 2182 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925318](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925318.md) | A-DEC 2181 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925317](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/K925317.md) | A-DEC 2180 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE | | [K925316](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC/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 - Ritter Co. — 2 clearances - Planmeca USA, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KLC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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