FDA Registration
Active
🇺🇸 United States
Standard Abutment Titanium Screw
Reg #: 1038806
·
FEI: 1038806
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOMET 3i, LLC
- Registration Number
- 1038806
- FEI Number
- 1038806
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4555 Riverside Drive
- City
- Palm Beach Gardens
- State
- FL
- ZIP
- 33410
- Country
- US
Regulatory Submissions
- 510(k) Number
- K871863
Owner / Operator
- Firm Name
- Biomet 3i
- Operator Number
- 1038806
- Address
- 4555 Riverside Drive, --
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
- Correspondent
- Ruth Lopez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-04-04 |
Proprietary Names
Standard Abutment Titanium Screw
Conical Abutment Screw
Establishment Types
Manufacture Medical Device