FDA Registration
Active
🇺🇸 United States
3D Accuscan Patient-Specific® Implant
Reg #: 2028924
·
FEI: 1000142697
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- IMPLANTECH ASSOCIATES, INC.
- Registration Number
- 2028924
- FEI Number
- 1000142697
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6025 NICOLLE ST., SUITE B
- City
- Ventura
- State
- CA
- ZIP
- 93003
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200610
Owner / Operator
- Firm Name
- IMPLANTECH ASSOCIATES, INC.
- Operator Number
- 9000198
- Address
- 6025 NICOLLE ST., SUITE B, --
- City
- Ventura
- State
- CA
- Postal Code
- 93003
- Country
- US
- Correspondent
- CRAIG A ARTHUR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | Class 2 | General, Plastic Surgery | No | 2022-08-12 |
| Elastomer, Silicone Block | MIB | Class 2 | Ear, Nose, Throat | No | 2022-08-12 |
| Prosthesis, Chin, Internal | FWP | Class 2 | General, Plastic Surgery | No | 2022-08-12 |
| Implant, Muscle, Pectoralis | MIC | Class 2 | Ear, Nose, Throat | No | 2022-08-12 |
Proprietary Names
3D Accuscan Patient-Specific® Implant
Establishment Types
Manufacture Medical Device