Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008519369

FEI Number

3008519369

Entity Name

NICHROMINOX

City/State/Country

SAINT BONNET DE MURE Rhone, FR

Establishment Address

18 RUE DES FRERES LUMIERE, SAINT BONNET DE MURE Rhone 69720, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

NICHROMINOX (Owner Number: 10044242)

Owner / Operator Contact Address

18 RUE DES FRERES LUMIERE, SAINT BONNET DE MURE, FR-69 69720, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GALAXIE 1/2 DIN ,10 INSTRUMENTS CASSETTE - AEC1/2DIN GALAXIE SURGICAL DIN CASSETTE - AESCDIN GALAXIE SCISSORS CLIPS - AESCLIPS GALAXIE BASE RAIL STANDARD FOR 10 INSTR - AECRAIL GALAXIE COMPRESSION RAIL - AECCRAIL GALAXIE NEEDLE HOLDERS CLIPS - AESCLIPNH GALAXIE 1/4 DIN, 5 INSTRUMENTS CASSETTE - AEC1/4DIN GALAXIE RETENTION RAIL FOR 10 INSTR - AECAGRAIL GALAXIE CLIP ASSEMBLING TOOL - AESCTOOL GALAXIE SURGICAL CONTAINER CASSETTE - AESCCON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-07-23
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-09-18
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2019-01-22

Official Correspondent

ERIC LEFRANCQ-LUMIERE

US Agent Details

Ann Marie Boullie Business: Casus Consulting LLC Email: USAgent@casusconsulting.com Phone: (972) 5326357

Related Public Records

Same Entity

NICHROMINOX

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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008519369. Last updated year: 2026. Please use registration number 3008519369 when referencing this establishment in official correspondence.