FDA Registration
Active
🇺🇸 United States
ZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA
Reg #: 2023141
·
FEI: 2023141
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZIMMER DENTAL INC.
- Registration Number
- 2023141
- FEI Number
- 2023141
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1900 ASTON AVE
- City
- CARLSBAD
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080164
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 |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2016-12-12 |
Proprietary Names
ZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA
ZIMMER ZFX ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA
Zimmer ZFX
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility