FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINILINE BRACKET
K Number: K881789
·
Decision Jun 1, 1988
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
4
Review Days
36
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Basic Information
- Device Name
- MINILINE BRACKET
- K Number
- K881789
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alexotek Co.
- Date Received
- April 26, 1988
- Decision Date
- June 1, 1988
- Product Code
- EJF
- 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 |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | FDA class 1 | Dental |
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