FDA Registration
Active
🇺🇸 United States
AD Protraction Facemask
Reg #: 2029096
·
FEI: 1000160800
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTHO KINETICS CORP.
- Registration Number
- 2029096
- FEI Number
- 1000160800
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2588 Progress St Ste 13
- City
- VISTA
- State
- CA
- ZIP
- 92081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K923556
Owner / Operator
- Firm Name
- ORTHO KINETICS CORP.
- Operator Number
- 9009331
- Address
- 2588 PROGRESS ST., SUITE 13, --
- City
- Vista
- State
- CA
- Postal Code
- 92081
- Country
- US
- Correspondent
- STEVEN O LUSE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2021-06-10 |
Proprietary Names
AD Protraction Facemask
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)