FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BISCOVER LED
K Number: K051999
·
Decision Aug 22, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
50
Applicant Total
79
Review Days
28
Basic Information
- Device Name
- BISCOVER LED
- K Number
- K051999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3310
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BISCO, INC.
- Date Received
- July 25, 2005
- Decision Date
- August 22, 2005
- Product Code
- EBD
- 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 |
|---|---|---|---|
| EBD | Coating, Filling Material, Resin | FDA class 2 | Dental |
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