EBA — Light, Surgical Headlight Class I
FDA product code EBA covers "Light, Surgical Headlight", a Class I medical device regulated under 21 CFR 872.4630. Submissions are reviewed by the Dental panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EBA
- Device Class
- Class I
- Regulation Number
- 872.4630
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070287 | Photonic Optische Gerate Gmbh And Cokg | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Feb 12, 2007 |
| K923949 | Sylvan Medical Fiberoptics | SYLVAN DENTAL HEADLIGHT SYSTEM | Oct 16, 1992 |
| K893458 | Cuda Products | FIBEROPTIC HEADLIGHT SYSTEM | Jun 22, 1989 |
| K854646 | Alpine Dental Equipment | VEGA DENTAL OPERATING LIGHT | Mar 6, 1986 |
| K842515 | Good-Lite | SURGICAL HEADLIGHT | Aug 2, 1984 |
| K842358 | Planmeca Usa | ISOLIGHT | Jul 31, 1984 |
| K822265 | Kelleher | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Sep 28, 1982 |
| K810117 | Colmed | HALOGEN HEADLIGHT SYSTEM | Feb 10, 1981 |
| K790806 | Harry J. Bosworth | PORCELIT | Aug 3, 1979 |
| K790807 | Harry J. Bosworth | METALIT | Aug 3, 1979 |