Chair, Dental, With Operative Unit
FDA product code KLC · Class I (low risk) · 21 CFR 872.6250 · Dental
63510(k) clearances
0PMA approvals
7recalls
Manufacturers
- A-Dec, Inc. 18
- Oriola OY Finndent 7
- Alpine Dental Equipment Co. 4
- Healthpak, Inc. 2
- Den-Tal-Ez Mfg Co., Inc. 2
- Planmeca USA, Inc. 2
- Ritter Co. 2
- Chayes Virginia, Inc. 2
- Pelton & Crane Co. 2
- Kaycor Intl., Ltd. 1
- Hillcrest Biologicals 1
- Swedish Dental Products, Inc. 1
- Lic-Orthion 1
- Sybron Corp. 1
- Sds Dental, Inc. 1
- E.F. Brewer Co. 1
- Fimet OY 1
- Halton Furniture Mfg. 1
- Siemens Corp. 1
- Dentis Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233921 | Luvis Chair (LC700C)KLC · Traditional | Dentis Co., Ltd. | 09/06/2024SE |
| K151987 | DCI Edge Dental Chair with Operative UnitKLC · Traditional | Dci | 06/01/2016SE |
| K071353 | Foshion Chair Mounted Dental, Model FJ48CKLC · Traditional | Shanghai Foshion Medical Instruments Co., Ltd. | 12/14/2007SE |
| K971063 | Optima Plus E Dental Chair; a Dental Chair; Excel ChairKLC · Traditional | King Dental Corp. | 06/03/1997SE |
| K963209 | Prostyle CompactKLC · Traditional | Planmeca Oy | 10/24/1996SE |
| K942870 | Ultima 2 Dental ChairKLC · Traditional | Dentech Corp. | 02/27/1995SE |
| K940950 | Kavo Systematica 1060KLC · Traditional | Kavo America | 12/29/1994SE |
| K925567 | E 4000 Dental Operating ChairKLC · Traditional | Dentalez Group | 03/10/1994SE |
| K925119 | A-Dec 1040 ChairKLC · Traditional | A-Dec, Inc. | 01/31/1994SE |
| K923534 | PM2002 ProlineKLC · Traditional | Planmeca USA, Inc. | 01/31/1994SE |
| K925325 | A-Dec 2185 Doctor's UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925324 | A-Dec 2184 Duo UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925323 | A-Dec 2183 Duo Unit, CuspKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925322 | A-Dec 2147 Doctor's UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925321 | A-Dec 2146 Duo UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925320 | A-Dec 2145 Duo Unit, CuspKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925319 | A-Dec 2182 Doctor's UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925318 | A-Dec 2181 Duo UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925317 | A-Dec 2180 Duo Unit, CuspKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925316 | A-Dec 2172 Doctor's UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925315 | A-Dec 2171 Duo UnitKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K925314 | A-Dec 2170 Duo Unit CuspKLC · Traditional | A-Dec, Inc. | 12/09/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | Mdt Corp., Inc. | 05/20/1993SE |
| K923461 | PM2002 Proline, PM2002 Proline EcKLC · Traditional | Planmeca USA, Inc. | 12/21/1992SE |
| K922175 | Healthpak Chair Sox BarriersKLC · Traditional | Healthpak, Inc. | 08/06/1992SE |
| K923306 | Healthpak Utility Sox BarriersKLC · Traditional | Healthpak, Inc. | 08/05/1992SE |
| K920017 | Improved Dental Operating LightKLC · Traditional | Den-Tal-Ez Mfg Co., Inc. | 03/02/1992SE |
| K920016 | Improved Dental ChairKLC · Traditional | Den-Tal-Ez Mfg Co., Inc. | 03/02/1992SE |
| K913535 | A-Dec Decade 1020 ChairKLC · Traditional | A-Dec, Inc. | 10/09/1991SE |
| K913059 | A-Dec Kneebreak 1030 ChairKLC · Traditional | A-Dec, Inc. | 10/08/1991SE |
| K903454 | A-Dec Decade 1010 ChairKLC · Traditional | A-Dec, Inc. | 10/24/1990SE |
| K903450 | A-Dec Decade 1015 ChairKLC · Traditional | A-Dec, Inc. | 10/24/1990SE |
| K896602 | FD5000 Dental ChairKLC · Traditional | Oriola OY Finndent | 02/14/1990SE |
| K894060 | Esse Quattro/Esse UnoKLC · Traditional | Eurodent, Inc. | 09/07/1989SE |
| K893944 | FD 300 Dental StoolKLC · Traditional | Oriola OY Finndent | 08/15/1989SE |
| K893943 | FD 200 Dental StoolKLC · Traditional | Oriola OY Finndent | 08/15/1989SE |
| K893890 | FD4500 (Dental Chair)KLC · Traditional | Oriola OY Finndent | 08/15/1989SE |
| K893889 | FD3500 (Dental Chair)KLC · Traditional | Oriola OY Finndent | 08/15/1989SE |
| K893945 | FD 350 Dental StoolKLC · Traditional | Oriola OY Finndent | 08/11/1989SE |
| K893946 | FD 400 Dental StoolKLC · Traditional | Oriola OY Finndent | 08/08/1989SE |
| K893454 | Chair/Stool Unit Dental Oper., Portable, FieldKLC · Traditional | Atlantic Industries, Inc. | 07/25/1989SE |
| K893045 | A-Dec Priority 1005 ChairKLC · Traditional | A-Dec, Inc. | 07/14/1989SE |
| K884304 | Ortho Patient ChairKLC · Traditional | Halton Furniture Mfg. | 04/25/1989SE |
| K884830 | Dental Chair F1KLC · Traditional | Fimet OY | 02/10/1989SE |
| K883437 | Dental ChairKLC · Traditional | E.F. Brewer Co. | 10/12/1988SE |
| K880475 | Skema (Dental Unit)KLC · Traditional | Alpine Dental Equipment Co. | 09/23/1988SE |
| K880474 | Area (Dental Chair)KLC · Traditional | Alpine Dental Equipment Co. | 09/23/1988SE |
| K863016 | Dentatus L SetKLC · Traditional | Sds Dental, Inc. | 10/01/1986SE |
| K863484 | Siemens Sirona(R) Dental ChairKLC · Traditional | Pelton & Crane Co. | 09/19/1986SE |
| K854647 | Polo Dental UnitKLC · Traditional | Alpine Dental Equipment Co. | 06/05/1986SE |
| K854644 | Manta Dental ChairKLC · Traditional | Alpine Dental Equipment Co. | 01/23/1986SE |
| K843233 | Anatom SystemKLC · Traditional | Lic-Orthion | 10/25/1984SE |
| K843436 | Dental ChairKLC · Traditional | Swedish Dental Products, Inc. | 09/27/1984SE |
| K822095 | Herpes-Iha KitKLC · Traditional | Hillcrest Biologicals | 04/05/1983SE |
| K822740 | K30000 Dental ChairKLC · Traditional | Kaycor Intl., Ltd. | 09/28/1982SE |
| K800276 | Ritter Model H Companion StoolKLC · Traditional | Sybron Corp. | 03/17/1980SE |
| K800172 | SiroportKLC · Traditional | Siemens Corp. | 02/05/1980SE |
| K800084 | Ritter Model J Dental ChairKLC · Traditional | Ritter Co. | 01/29/1980SE |
| K772300 | Dental Chair, VanguardKLC · Traditional | Ritter Co. | 01/03/1978SE |
| K771873 | Vision Series Dental ChairKLC · Traditional | Chayes Virginia, Inc. | 10/25/1977SE |
| K760599 | Dental ChairsKLC · Traditional | Chayes Virginia, Inc. | 09/15/1976SE |
| K760404 | Bi-Centric SystemKLC · Traditional | Pelton & Crane Co. | 08/23/1976SE |
| K760322 | Chair, Attached Instrument Del. Sys.KLC · Traditional | The S. S. White Co. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1326-2010 | Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane…Magnetic headrests may affect patients with implantable pacemakers and defibrillators. | Pelton & Crane Company | 02/24/2010Terminated |
| Z-1325-2010 | Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane…Magnetic headrests may affect patients with implantable pacemakers and defibrillators. | Pelton & Crane Company | 02/24/2010Terminated |
| Z-1324-2010 | Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane…Magnetic headrests may affect patients with implantable pacemakers and defibrillators. | Pelton & Crane Company | 02/24/2010Terminated |
| Z-1180-2010 | Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane…Magnetic headrests may affect patients with implantable pacemakers and defibrillators. | Pelton & Crane Company | 02/24/2010Terminated |
| Z-1179-2010 | Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane…Magnetic headrests may affect patients with implantable pacemakers and defibrillators. | Pelton & Crane Company | 02/24/2010Terminated |
| Z-1311-2010 | Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly…The Dental Chair lacks a valid Device History Record. | Pelton & Crane Company | 02/09/2010Terminated |
| Z-0541-2011 | A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient…The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest… | A-Dec Inc | 04/01/2009Terminated |