FDA Registration
Active
🇩🇰 Denmark
Rescue Drill Guide Trioval Conical Connection
Reg #: 3007689689
·
FEI: 3007689689
·
Expires 2025
Products
1
Proprietary Names
11
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
- K211109
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 | 2022-01-20 |
Proprietary Names
Rescue Drill Guide Trioval Conical Connection
Implant Driver Trioval Conical Connection
Manual Torque Wrenche Prosthetic
Direction Indicator
Bone Mill Guide for N1
OsseoShaper Extension
Bone Mill for N1 Trioval Conical Connection
Abutment Retrieval Tools/Instruments Titanium
Depth Probe
Manual Torque Wrenche Surgical
Machine Omnigrip Mini Screwdriver
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)