FDA Registration
Active
🇩🇰 Denmark
NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro
Reg #: 3007689689
·
FEI: 3007689689
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELOS MEDTECH PINOL A/S
- Registration Number
- 3007689689
- FEI Number
- 3007689689
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Engvej 33
- City
- Goerloese Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K952676
Owner / Operator
- Firm Name
- Elos Medtech Pinol A/S
- Operator Number
- 10029200
- Address
- Engvej 33
- City
- Goerloese
- State
- Hovedstaden
- Postal Code
- DK3330
- Country
- DK
- Correspondent
- Lise Terkelsen
US Agent
- Business Name
- ONYX MEDICAL CORPORATION
- Contact Name
- JODIE GILMORE
- Address
- 1800 North Shelby Oaks Drive
- City
- Memphis
- State
- TN
- ZIP
- 38134
- Country
- US
- [email protected]
- Phone
- 901 3236699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2010-12-15 |
Proprietary Names
NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)