FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIBERBOND
K Number: K864376
·
Decision Apr 7, 1987
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
3
Applicant Total
3
Review Days
153
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Basic Information
- Device Name
- FIBERBOND
- K Number
- K864376
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5525
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentec, Inc.
- Date Received
- November 5, 1986
- Decision Date
- April 7, 1987
- Product Code
- DYT
- 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 |
|---|---|---|---|
| DYT | Maintainer, Space Preformed, Orthodontic | FDA class 1 | Dental |
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