FDA Registration
Active
🇮🇱 Israel
Manual Hex Driver
Reg #: 3009161350
·
FEI: 3009161350
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PALTOP ADVANCED DENTAL SOLUTIONS LTD
- Registration Number
- 3009161350
- FEI Number
- 3009161350
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hashita 5, Industrial Park
- City
- Caesarea Central
- Country
- IL
Owner / Operator
- Firm Name
- Paltop Advanced Dental Solutions Inc.
- Operator Number
- 10043196
- Address
- 13645 Alton Pkwy Ste A
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-07-21 |
Proprietary Names
Manual Hex Driver
Torque Ratchet
Hex Key
I-HEXMRT Dental Implant System
Prima Plus Implant Driver
Extractor for Abutment Screw
Hex Key Insertion Bit
Abutment Screw Retrieval Instrument
TiLobe® Guided Implant Driver
Extractor
Prima Dental Implant System
Hex Driver
Ratchet
Genesis Implant System
Core Tool
Quad Driver
Ratchet Adapter
RESTORE Dental Implant System
Implant Insertion Key
Key Ratchet Adapter
Hand Piece Straight
STAGE-1 Dental Implant System
Implant Hex Positioning Key
Guide Handle
Prima Surgical Hand Driver
Guided Implant Driver
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device