EBA · Light, Surgical Headlight
Dental · 21 CFR 872.4630 · Class 1
Overview
| Product Code | EBA |
|---|---|
| Device Name | Light, Surgical Headlight |
| Regulation | 21 CFR 872.4630 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | Feb 12, 2007 | SESE |
| K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics | Oct 16, 1992 | SESE |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | Jun 22, 1989 | SESE |
| K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | Mar 6, 1986 | SESE |
| K842515 | SURGICAL HEADLIGHT | Good-Lite Co. | Aug 2, 1984 | SESE |
| K842358 | ISOLIGHT | Planmeca USA, Inc. | Jul 31, 1984 | SESE |
| K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | Sep 28, 1982 | SESE |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | Feb 10, 1981 | SESE |
| K790807 | METALIT | Harry J. Bosworth Co. | Aug 3, 1979 | SESE |
| K790806 | PORCELIT | Harry J. Bosworth Co. | Aug 3, 1979 | SESE |
Top Applicants
- Harry J. Bosworth Co. — 2 clearances
- Sylvan Medical Fiberoptics — 1 clearance
- Planmeca USA, Inc. — 1 clearance
- Photonic Optische Gerate GmbH & Cokg — 1 clearance
- Kelleher Corp. — 1 clearance
