FDA Registration
Active
🇺🇸 United States
ORTHONE INC.
Reg #: 3034278341
·
FEI: 3034278341
·
Expires 2026
Products
14
Proprietary Names
6
Establishment Types
1
Classifications
14
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Registration Details
- Registration Name
- ORTHONE INC.
- Registration Number
- 3034278341
- FEI Number
- 3034278341
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 300 Delaware Ave Suite 210 2207 Wilmington De 19801
- City
- Wilmington
- State
- DE
- ZIP
- 19801
- Country
- US
Owner / Operator
- Firm Name
- Orthone INC.
- Operator Number
- 10092184
- Address
- 300 Delaware Avenue, Suite 210-2207, Wilmington, DE 19801
- City
- Wilmington
- State
- DE
- Postal Code
- 19801
- Country
- US
- Correspondent
- Anita Ke
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2024-12-12 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2024-12-12 |
| Floss, Dental | JES | Class 1 | Dental | No | 2025-12-25 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2024-12-12 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-12-12 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2024-12-12 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2025-12-25 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2024-12-12 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2025-12-25 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2024-12-12 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2024-12-12 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2024-12-12 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2024-12-12 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2024-12-12 |
Proprietary Names
orthone, Forceps, Dental Tweezers
orthone
orthone, Toothpaste
orthone, Orthodontic wax, Orthodontic Wax
orthone, Orthodontic Indirect Bonding Tray, OBRACE GUIDE
orthone, Orthodontic Forceps
Establishment Types
Repack or Relabel Medical Device