Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016672944

FEI Number

3016672944

Entity Name

ALPHA-BIO TEC

City/State/Country

Modi'in Central, IL

Establishment Address

21 HaReches Blvd., POB 264, Modi'in, Modi'in Central 7171102, IL

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Alpha-Bio Tec (Owner Number: 10095210)

Owner / Operator Contact Address

21 HaReches Blvd., POB 264, Modi'in, Modi'in, IL-M 7171102, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-02-10

Official Correspondent

Shani Aroch

US Agent Details

Jenny Le Email: Jenny.Le@envistaco.com Phone: (714) 2825095

Related Public Records

Same Entity

Alpha-Bio Tec

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3017896270	EXCELLENT PRECISION TECHNOLOGY (DONGGUAN) CO., LTD	Dongguan Guangdong, CN
3042200066	HUB BIOTECH CO., LTD.	BUCHEON-SI Gyeonggi, KR
3042852773	COVISION CO., LTD.	Incheon, KR
3009847764	GMI DENTAL IMPLANTOLOGY, S.L.	Lleida Lerida, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016672944. Last updated year: 2026. Please use registration number 3016672944 when referencing this establishment in official correspondence.