Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012084997

FEI Number

3012084997

Entity Name

GATE DENTAL SERVICES LTD

City/State/Country

Galway, IE

Establishment Address

Garrynagry, Roscahill, Galway none, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) (Owner Number: 10052726)

Owner / Operator Contact Address

Garrynagry, Roscahill, Galway, IE-G none, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Spandex Advanced

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2025-02-10

Official Correspondent

PAUL MOORE

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

GATE DENTAL SERVICES LTD ( T/A DentalOrganiser)

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

View Entity Profile →

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1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US
3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3011585752	HANGZHOU HAIZHU MIM PRODUCTS CO., LTD	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012084997. Last updated year: 2026. Please use registration number 3012084997 when referencing this establishment in official correspondence.