Vega Dental Operating Light
FDA 510(k) K854646 · Alpine Dental Equipment Co.
510(k) numberK854646
Submission
- Device name
- Vega Dental Operating Light
- Applicant
- Alpine Dental Equipment Co.
East Orange, NJ, US - Received
- November 19, 1985
- Decision date
- March 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500EBA · Traditional | Photonic Optische Gerate GmbH & Cokg | 02/12/2007SE |
| K923949 | Sylvan Dental Headlight SystemEBA · Traditional | Sylvan Medical Fiberoptics | 10/16/1992SE |
| K893458 | Fiberoptic Headlight SystemEBA · Traditional | Cuda Products Co. | 06/22/1989SE |
| K842515 | Surgical HeadlightEBA · Traditional | Good-Lite Co. | 08/02/1984SE |
| K842358 | IsolightEBA · Traditional | Planmeca USA, Inc. | 07/31/1984SE |
| K822265 | Fiberoptic Light Source W/Related ItemsEBA · Traditional | Kelleher Corp. | 09/28/1982SE |
| K810117 | Halogen Headlight SystemEBA · Traditional | Colmed, Ltd. | 02/10/1981SE |
| K790807 | MetalitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
| K790806 | PorcelitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
More from Harry J. Bosworth Co.
| 510(k) | Device | Decision |
|---|---|---|
| K880475 | Skema (Dental Unit)KLC · Traditional | 09/23/1988SE |
| K880474 | Area (Dental Chair)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 |
| K854644 | Manta Dental ChairKLC · Traditional | 01/23/1986SE |
Questions and answers
When was Vega Dental Operating Light cleared by the FDA?
Vega Dental Operating Light (K854646) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 107 days after the submission was received.
What is the product code of K854646?
The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.