Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008579121

FEI Number

3008579121

Entity Name

DENTAL HI TEC

City/State/Country

Mazieres en Mauges Maine-et-Loire, FR

Establishment Address

Rue de Champs Blanc, Mazieres en Mauges Maine-et-Loire 49280, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dental Hi Tec (Owner Number: 10059566)

Owner / Operator Contact Address

Rue de Champs Blanc, Mazieres en Mauges, FR-49 49280, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QuickSleeper5 Effitec needles Soan SleeperOne5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGM	Injector, Jet, Mechanical-Powered	Dental	Class 2	872.4475	2025-09-03
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2025-09-03
DZM	Needle, Dental	Dental	Class 1	872.4730	2023-05-09
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2019-01-31

Official Correspondent

Olivier Villette

US Agent Details

Mohammad Sargazi Business: Dentalhitec Americas Email: msargazi@dentalhitec.us Phone: (346) 5846363

Related Public Records

Same Entity

Dental Hi Tec

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 3008579121. Last updated year: 2026. Please use registration number 3008579121 when referencing this establishment in official correspondence.