Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005164841

FEI Number

3005164841

Entity Name

FORUM ENGINEERING TECHNOLOGIES (96) LTD.

City/State/Country

Ashkelon Southern, IL

Establishment Address

40 Hutsot HaYotser St., South Industrial Zone, Ashkelon Southern 7878563, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Forum Engineering Technologies (96) Ltd. (Owner Number: 10038791)

Owner / Operator Contact Address

40 Hutsot HaYotser St., South Industrial Zone, Ashkelon, IL-NOTA 7878563, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111474

PMA Number

N/A

All Registered Proprietary Names

RomiApex A-15, Apex Locator Endo-Eze® Find, Apex Locator Spotter Statera vi X-Smart Go EM-07 Cordless Endo Motor CanalPro BINGO PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQY	Locator, Root Apex	Unknown	Class U	N/A	2020-01-27
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-01-28
LQY	Locator, Root Apex	Unknown	Class U	N/A	2024-07-23
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2024-07-23
LQY	Locator, Root Apex	Unknown	Class U	N/A	2011-11-13

Official Correspondent

Nissim Oz

US Agent Details

George Hattub Business: Medicsense USA Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

Forum Engineering Technologies (96) Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21

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
9614866	ADVANCED TECHNOLOGY RESEARCH S.R.L.	PISTOIA, IT
2127132	ENOVA ILLUMINATION, INC	Minneapolis, MN, US
2411797	PARKELL, INC.	EDGEWOOD, NY, US
3012477813	Kerr Corporation	Pomona, CA, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005164841. Last updated year: 2026. Please use registration number 3005164841 when referencing this establishment in official correspondence.