FDA Registration
Active
🇺🇸 United States
KLOwen Orthodontic Solution
Reg #: 3030265369
·
FEI: 3030265369
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KLOWEN BRACES DBA KLOWEN ORTHODONTICS
- Registration Number
- 3030265369
- FEI Number
- 3030265369
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1703 N. Plano Road, Ste. 200
- City
- Richardson
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251196
Owner / Operator
- Firm Name
- KLOwen Braces dba KLOwen Orthodontics
- Operator Number
- 10089784
- Address
- 1703 N. Plano Road, Ste. 200
- City
- Richardson
- State
- TX
- Postal Code
- 75081
- Country
- US
- Correspondent
- Tony Sapp
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2025-05-08 |
Proprietary Names
KLOwen Orthodontic Solution
Establishment Types
Repack or Relabel Medical Device