Area (Dental Chair)
FDA 510(k) K880474 · Alpine Dental Equipment Co.
510(k) numberK880474
Submission
- Device name
- Area (Dental Chair)
- Applicant
- Alpine Dental Equipment Co.
East Orange, NJ, US - Received
- February 4, 1988
- Decision date
- September 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KLC
| 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 |
More from Planmeca USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880475 | Skema (Dental Unit)KLC · Traditional | 09/23/1988SE |
| K854647 | Polo Dental UnitKLC · Traditional | 06/05/1986SE |
| K854643 | SolarEIA · Traditional | 03/14/1986SE |
| K854642 | Solar CartEIA · Traditional | 03/14/1986SE |
| K854645 | Gold Air, Gold LightEFB · Traditional | 03/12/1986SE |
| K854641 | Solar FEIA · Traditional | 03/10/1986SE |
| K854741 | X-Range 65EHD · Traditional | 03/06/1986SE |
| K854646 | Vega Dental Operating LightEBA · Traditional | 03/06/1986SE |
| K854644 | Manta Dental ChairKLC · Traditional | 01/23/1986SE |
Questions and answers
When was Area (Dental Chair) cleared by the FDA?
Area (Dental Chair) (K880474) received a 510(k) decision of Substantially Equivalent on September 23, 1988, 232 days after the submission was received.
What is the product code of K880474?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.