FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET
K Number: K874226
·
Decision Dec 29, 1987
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
4
Review Days
74
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Basic Information
- Device Name
- STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET
- K Number
- K874226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Advanced Orthodontics Systems, Inc.
- Date Received
- October 16, 1987
- Decision Date
- December 29, 1987
- 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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