FDA Registration
Active
🇮🇱 Israel
Cover screws, Healing abutments, Temporary abutments, Prepable straight abutments, Angled abutment,
Reg #: 3010948854
·
FEI: 3010948854
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DITRON DENTAL LTD
- Registration Number
- 3010948854
- FEI Number
- 3010948854
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Haofe St., Southern Industrial Zone
- City
- Ashkelon Southern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K203240
Owner / Operator
- Firm Name
- Ditron Dental Ltd
- Operator Number
- 10049877
- Address
- 2 Haofe St., Southern Industrial Zone
- City
- Ashkelon
- State
- Southern
- Postal Code
- 7878002
- Country
- IL
- Correspondent
- Ariel Zuhovitzky
US Agent
- Business Name
- First Capital Advisers LLC
- Contact Name
- Levent Sadikoglu
- Address
- 420 Lexington Ave Rm 1402
- City
- New York
- State
- NY
- ZIP
- 10170
- Country
- US
- [email protected]
- Phone
- 212 3170020
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-11-18 |
Proprietary Names
Cover screws, Healing abutments, Temporary abutments, Prepable straight abutments, Angled abutment,
Abutment, Implant, Dental Endosseous
Castable base abutment (Co- Cr- Mo alloy, Multi-unit abutments, Titanium base abutments, Titanium blank abutments,
Abutment multi post screw, Multi-unit abutment screw, Multi-unit prosthetic screw.
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)