FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLASTIC CHAIN
K Number: K925012
·
Decision Sep 13, 1993
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
102
Applicant Total
39
Review Days
346
Basic Information
- Device Name
- PLASTIC CHAIN
- K Number
- K925012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AMERICAN ORTHODONTICS
- Date Received
- October 2, 1992
- Decision Date
- September 13, 1993
- 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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