FDA Registration
Active
🇺🇸 United States
Tritanium
Reg #: 2126683
·
FEI: 2126683
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- AMERICAN ORTHODONTICS
- Registration Number
- 2126683
- FEI Number
- 2126683
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3524 Washington Ave
- City
- SHEBOYGAN
- State
- WI
- ZIP
- 53081
- Country
- US
Owner / Operator
- Firm Name
- AMERICAN ORTHODONTICS
- Operator Number
- 2126683
- Address
- 3524 Washington Avenue, --
- City
- Sheboygan
- State
- WI
- Postal Code
- 53081
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1992-07-13 |
Proprietary Names
Tritanium
Multiphase Blue Chromium Cobalt Wire
Wrap Around Hawley Retainer
Everwhite Wire
Stainless Steel Retainer Wire
Force Two NiTi Wire
Superelastic Titanium Memory
Ball Retainer Clasps
Ligature Wire
Stainless Steel Wire
Tanzo
Beta Titanium Wire
Therma-Ti
NT3
Orientation Pin
Kobayashi Hooks
Power Pin
Therma-Ti "D"
Stainless Steel Multi-Strand
Therma-Ti Lite
Iconix
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198