Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613283

FEI Number

3004471724

Entity Name

HI TEC IMPLANTS, LTD.

City/State/Country

HERZLIA Tel Aviv, IL

Establishment Address

20 GALGALEI PLADA ST., HERZLIA Tel Aviv 46722, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HI TEC IMPLANTS, LTD. (Owner Number: 9010116)

Owner / Operator Contact Address

20 GALGALEI PLADA ST., --, HERZLIA, IL-NOTA 46722, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FSD RTD-EX.IR CSD CSD-EX.IR RB-EX.IR TF 2 FSD-EX.IR PD-EX.IR WTD-EX.IR PD RTD GTD-EX.IR XTD STD NTD TF2.8 TF 3.5 WTD XTD-EX.IR NTD-EX.IR TF 4.2 GTD STD-EX.IR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJL	Bur, Dental	Dental	Class 1	872.3240	2006-04-05

Official Correspondent

Dr. Roy Leshem

US Agent Details

Benzy Arazy Business: Medes USA C/O Matan Arazy Email: Medes@Arazygroup.com Phone: (415) 9921126

Related Public Records

Same Entity

HI TEC IMPLANTS, LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613283. Last updated year: 2026. Please use registration number 9613283 when referencing this establishment in official correspondence.