KLC · Chair, Dental, With Operative Unit
Dental · 21 CFR 872.6250 · Class 1
Overview
| Product Code | KLC |
|---|---|
| Device Name | Chair, Dental, With Operative Unit |
| Regulation | 21 CFR 872.6250 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 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 | Luvis Chair (LC700C) | Dentis Co., Ltd. | Sep 6, 2024 | SESE |
| K151987 | DCI Edge Dental Chair with Operative Unit | Dci | Jun 1, 2016 | SESE |
| K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | Dec 14, 2007 | SESE |
| K971063 | OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR | King Dental Corp. | Jun 3, 1997 | SESE |
| K963209 | PROSTYLE COMPACT | Planmeca Oy | Oct 24, 1996 | SESE |
| K942870 | ULTIMA 2 DENTAL CHAIR | Dentech Corp. | Feb 27, 1995 | SESE |
| K940950 | KAVO SYSTEMATICA 1060 | Kavo America | Dec 29, 1994 | SESE |
| K925567 | E 4000 DENTAL OPERATING CHAIR | Dentalez Group | Mar 10, 1994 | SESE |
| K925119 | A-DEC 1040 CHAIR | A-Dec, Inc. | Jan 31, 1994 | SESE |
| K923534 | PM2002 PROLINE | Planmeca USA, Inc. | Jan 31, 1994 | SESE |
| K925325 | A-DEC 2185 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925324 | A-DEC 2184 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925323 | A-DEC 2183 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925322 | A-DEC 2147 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925321 | A-DEC 2146 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925320 | A-DEC 2145 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925319 | A-DEC 2182 DOCTOR'S UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925318 | A-DEC 2181 DUO UNIT | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925317 | A-DEC 2180 DUO UNIT, CUSP | A-Dec, Inc. | Dec 9, 1993 | SESE |
| K925316 | 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
