FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBREFLEX
K Number: K871312
·
Decision Apr 15, 1987
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
2
Review Days
14
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Basic Information
- Device Name
- FIBREFLEX
- K Number
- K871312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Biomedical Composites, Ltd.
- Date Received
- April 1, 1987
- Decision Date
- April 15, 1987
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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Other Clearances by Biomedical Composites, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K914035 | MINI-MILL | Mar 2, 1992 | Substantially Equivalent |