Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009736660

FEI Number

3009736660

Entity Name

MARUEMU WORKS CO.,LTD.

City/State/Country

Daitoshi Osaka, JP

Establishment Address

4-7-12, Nozaki, Daitoshi Osaka 574-0015, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

MARUEMU WORKS CO., LTD (Owner Number: 10041405)

Owner / Operator Contact Address

4-7-12, Nozaki, Daitoshi, JP-27 584-0015, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GUMMETAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2012-07-19

Official Correspondent

Kenichi Ishimoto

US Agent Details

Joseph Mazurkiewicz Business: GREAT LAKES DENTAL TECHNOLOGIES Email: JoeM@greatlakesdentaltech.com Phone: (800) 8287626

Related Public Records

Same Entity

MARUEMU WORKS CO., 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 3009736660. Last updated year: 2026. Please use registration number 3009736660 when referencing this establishment in official correspondence.