FDA Registration
Active
🇮🇱 Israel
ALPHA-BIO TEC
Reg #: 3016672944
·
FEI: 3016672944
·
Expires 2026
Products
1
Proprietary Names
114
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ALPHA-BIO TEC
- Registration Number
- 3016672944
- FEI Number
- 3016672944
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 21 HaReches Blvd., POB 264, Modi'in
- City
- Modi'in Central
- Country
- IL
Owner / Operator
- Firm Name
- Alpha-Bio Tec
- Operator Number
- 10095210
- Address
- 21 HaReches Blvd., POB 264, Modi'in
- City
- Modi'in
- State
- Central
- Postal Code
- 7171102
- Country
- IL
- Correspondent
- Shani Aroch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2026-02-10 |
Proprietary Names
Open tray transfer short R CHC
Alpha Step Drill_2.4/2.8
CS Advanced Surgical Organizer Box
Sirona CAD/CAM Scan Post-CS
Alpha Step Drill_4.5/4.8
Closed tray transfer for D3.5 MU
Alpha Drill Stopper C-D3.2-3.65 L6
Alpha Drill Stopper A-D2-2.4 L11.5
MU motor straight Driver
Motor TX driver vertical- Standard
Short Parallel Depth Guide
Alpha Drill Stopper C-D3.2-3.65 L11.5
Analog Printed Model insertion tool CS/IH
Alpha Drill Stopper B-D2.8-3 L13
Implant Driver Long 2.1mm CHC
Hand Hex Screw Driver 1.25mm
TRZ Scan Body CHC
Implant Depth Probe
Retriever driver MUA
Universal Torque Ratchet 10-45Ncm
Alpha Drill Stopper B-D2.8-3 L11.5
Alpha Drill Stopper D-D4.1-4.5 L11.5
Parallel Depth Guide
Closed tray transfer short-CS
Retrieval Screw
Drill Extension L17.5mm
Ratchet TX driver vertical- Long
Motor TX driver angled-Long
Motor Mount Hex Driver 1.25mm
Alpha Drill Stopper C-D3.2-3.65 L10
Implant Analog CHC
Marking Drill
Alpha Drill Stopper B-D2.8-3 L10
Alpha Step Drill_2.8/3.2
Open tray transfer short AR -CS
Motor Mount Driver Long 2.1mm CHC
Snap transfer CHC
Open tray transfer Long AR CHC
Alpha Drill Stopper D-D4.1-4.5 L8
Analog for printed model CS
Open tray transfer for D3.5 MU R
Open tray transfer short R-CS
Alpha Drill Stopper B-D2.8-3 L8
Analog for D4.8 MU
Countersink Drill D2.7-5.9mm
Implant Driver Long 2.5mm CS
MU motor straight Driver - Long
Implant Hand Driver 2.1mm CHC
Trephine Drill D4mm
Drilling Parallel Guide
Casting sleeve for D3.5 MU R
Alpha Straight Drill_D2
Long Hex Driver 1.25mm
Alpha Step Drill_4.1/4.5
Open tray transfer Long AR CS
Manual TX driver angled -Long
Implant Analog - CS
Analog for D3.5 MU
Alpha Step Drill_2/2.4
Alpha Drill Stopper A-D2-2.4 L10
Alpha Drill Stopper D-D4.1-4.5 L10
Manual TX driver vertical - Long
Manual TX driver angled - Standard
Alpha Drill Stopper C-D3.2-3.65 L8
Casting sleeve for D4.8 MU R
Motor Mount Driver Short 2.5mm CS
Plastic cap for closed tray transfer package (10
Motor Mount Driver Long 2.5mm CS
Alpha Drill Stopper A-D2-2.4 L6
TRZ Scan body for D4.8 MU
Snap transfer CS
Open tray transfer for D4.8 MU R
Digital analog for D4.8 MU
Mini Surgical Organizer Box W/O SS bath
Digital analog for D3.5 MU
Alpha Step Drill_3.2/3.65
TRZ Scan body CS
Alpha Step Drill_2.8/3
Manual Implant Driver 2.5mm CS
Short Hand Hex Screw Driver 1.25mm
Implant Driver Standard 2.1mm CHC
Alpha Drill Stopper D-D4.1-4.5 L6
Alpha Drill Stopper A-D2-2.4 L13
Trephine Drill D5mm
Retrieval Screw CHC
Implant Driver Short 2.1mm CHC
CHC analog tool
Manual TX driver vertical- Standard
Alpha Drill Stopper B-D2.8-3 L6
Alpha Drill Stopper C-D3.2-3.65 L13
Surgical Screwdriver
Motor TX driver vertical -Long
Alpha Drill Stopper A-D2-2.4 L8
Round Burr D3mm
Alpha Drill Stopper D-D4.1-4.5 L13
Closed tray transfer for D4.8 MU
Stopper Surgical Kit
Alpha Step Drill_3.65/4.1
Closed tray transfer -CHC
CAD/CAM CHC Analog for printed model
Open tray transfer Long R-CS
Open tray transfer short AR CHC
Ratchet TX driver vertical- Standard
Motor TX driver angled- Standard
Ratchet TX driver angled - Long
Short Hex Driver 1.25mm
Hex Driver 1.25mm
Ratchet TX driver angled- Standard
MU straight Driver
Alpha Step Drill_4.8/5.2
Implant Driver Short 2.5mm CS
Motor Mount Driver Short 2.1mm CHC
TRZ Scan body for D3.5 MU
Sirona CAD/CAM Scan Post-CHC
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198