FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HALOGEN HEADLIGHT SYSTEM
K Number: K810117
·
Decision Feb 10, 1981
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
9
Applicant Total
7
Review Days
25
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HALOGEN HEADLIGHT SYSTEM
- K Number
- K810117
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Colmed, Ltd.
- Date Received
- January 16, 1981
- Decision Date
- February 10, 1981
- Product Code
- EBA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBA | Light, Surgical Headlight | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBA), ordered by most recent decision date.
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
FDA 510(k)
FDA Class 1
·Dental
SYLVAN DENTAL HEADLIGHT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
FIBEROPTIC HEADLIGHT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
VEGA DENTAL OPERATING LIGHT
FDA 510(k)
FDA Class 1
·Dental
SURGICAL HEADLIGHT
FDA 510(k)
FDA Class 1
·Dental
ISOLIGHT
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Colmed, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K811209 | JACOB WIRZ TRANSFIXATION PIN | Jun 16, 1981 | Substantially Equivalent |
| K810636 | VARIODRAIN | May 1, 1981 | Substantially Equivalent |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | May 28, 1980 | Substantially Equivalent |
| K801006 | CHARNLEY DESIGN HIP PROSTHESIS | May 20, 1980 | Substantially Equivalent |
| K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | May 14, 1980 | Substantially Equivalent |
| K792241 | PELIMIT | Nov 30, 1979 | Substantially Equivalent |