FDA Registration
Active
🇺🇸 United States
Pre-Torqued SE Niti
Reg #: 3007284437
·
FEI: 3007284437
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTHO ARCH COMPANY INC
- Registration Number
- 3007284437
- FEI Number
- 3007284437
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1107 Tower Road
- City
- Schaumburg
- State
- IL
- ZIP
- 60173
- Country
- US
Owner / Operator
- Firm Name
- ORTHO ARCH COMPANY INC
- Operator Number
- 10030081
- Address
- 1107 Tower Road
- City
- Schaumburg
- State
- IL
- Postal Code
- 60173
- Country
- US
- Correspondent
- Jonathan Leng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2017-07-21 |
Proprietary Names
Pre-Torqued SE Niti
Heat Activated Niti
HA Niti with Copper
Black Satin SE Niti
SS Nic-O-Loy Keyhole 4-Loop Retraction Arch, SS T-Loop Retraction Arch, Beta-Titanium Mushroom-Loop Retraction Arch
Posted SS Archwire, SS Cuspid-Loop Retraction Arch, AJ Wilcock Vertical-Loop Retraction Arch
Reverse Curve of Spee SE Niti and RSC (Straight Leg) SE Niti
SE Nitinol Wire
Brehm Niti Utility Arch
Turbo-8 Braid SE Niti
AJ Wilcock Australian Wire 25" Spool and 14" Length Wire
Shorty Kobyashi Hooks
Multi Modulus (Multi-Force) HA Niti
Beta Titanium
HA Niti Finishing
Performed Ligature Wire, Toothtone Ligature Wire, Shorty Ligature Ties, Kobyashi Tie Hooks
D2 Appliance
Stainless Steel, SS Multi-Stranded Leveling, SS Keyhole 2-Loop Retraction Arch, SS Keyhople 4-Loop Retraction Arch
Nano Coated Super Elastic Nitinol Archwires
Establishment Types
Repack or Relabel Medical Device