FDA Registration
Active
🇺🇸 United States
3i T3 Ex Hex Tapered Implant
Reg #: 1038806
·
FEI: 1038806
·
Expires 2025
Products
1
Proprietary Names
4
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
- K133049
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 | 2014-01-15 |
Proprietary Names
3i T3 Ex Hex Tapered Implant
3i T3 with DCD Ex Hex Tapered Implant
3i T3 Ex Hex Parallel Walled Implant
3i T3 with DCD Ex Hex Parallel Walled Implant
Establishment Types
Manufacture Medical Device