FDA Registration
Active
🇺🇸 United States
Elos Accurate Customized Abutment, Straumann Bone Level, Nobel Replace (3.5), Nobel CC (3, 4.3, 6)
Reg #: 3012481042
·
FEI: 3012481042
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VULCAN CUSTOM DENTAL
- Registration Number
- 3012481042
- FEI Number
- 3012481042
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2300 Riverchase Center Suite 825
- City
- Hoover
- State
- AL
- ZIP
- 35244
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190299
Owner / Operator
- Firm Name
- Vulcan Custom Dental
- Operator Number
- 10051457
- Address
- 2300 Riverchase Center Suite 825
- City
- Hoover
- State
- AL
- Postal Code
- 35244
- Country
- US
- Correspondent
- Brett Muetzel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-10-29 |
Proprietary Names
Elos Accurate Customized Abutment, Straumann Bone Level, Nobel Replace (3.5), Nobel CC (3, 4.3, 6)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)