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
Accessories, Implant, Dental, Endosseous NDP

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