FDA Registration
Active
🇨🇦 Canada
3i T3 Ex Hex Tapered Implant
Reg #: 1000244346
·
FEI: 1000244346
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Zimmer Biomet Dental Canada Inc.
- Registration Number
- 1000244346
- FEI Number
- 1000244346
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2345 Argentia Rd, Suite 106
- City
- Mississauga Ontario
- Country
- CA
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
US Agent
- Business Name
- BIOMET 3I
- Contact Name
- Henrique Nomelini Muniz
- Address
- Palm Beach Gardens, 4555 Riverside Drive
- City
- Palm Beach Gardens
- State
- FL
- ZIP
- 33410
- Country
- US
- [email protected]
- Phone
- 561 7766700
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
Export Device to the United States But Perform No Other Operation on Device