Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009560600

FEI Number

3009560600

Entity Name

MARUCHI

City/State/Country

Wonju-si Gangwon, KR

Establishment Address

101, Donghwagongdan-ro, Munmak-eup, Wonju-si Gangwon 26365, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MARUCHI (Owner Number: 10040294)

Owner / Operator Contact Address

101, Donghwagongdan-ro, Munmak-eup, Wonju-si, KR-42 26365, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AH Plus® Bioceramic Sealer Endodontic Cannulas SendoCem MTA ENDOCEM MTA PREMIXED REGULAR AH Plus® Bioceramic Sealer White ENDOSEAL MTA White ENDOSEAL Bioceramic Sealer EndoSonic Metal ENDOSONIC BLUE Ni-Ti File ENDOSONIC BLUE Ni-Ti File 2 ENDOSONIC BLUE PLUS ENDOSONIC BLUE EndoRoad EndoRoad S EndoRoad N EndoRoad P VPT Orifice Shaper ENDOSONIC BLUE EMS PP file ENDOSEAL MTA ENDOSEAL BIOCERAMIC SEALER SendoSeal MTA CleaniCal ENDOSONIC BLUE KIT ENDOSONIC BLUE PORTABLE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZM	Needle, Dental	Dental	Class 1	872.4730	2021-08-19
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2023-03-08
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-08-19
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2015-12-21
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2018-02-26
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2021-02-16
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-02-16
JET	Pick, Massaging	Dental	Class 1	872.6650	2019-05-16

Official Correspondent

Sung-wook Jang

US Agent Details

Kevin Bang Business: KB Dental Products Inc Email: kevin@kbdentalusa.com Phone: (714) 5975851

Related Public Records

Same Entity

MARUCHI

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K941532	Bio-Probe, Inc.	BIOCALEX 6/9	1994-08-02
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Similar Registrations

Registration Number	Establishment Name	Location
3005416271	C-K DENTAL IND. CO., LTD.	BUCHEON-SI, GYEONGGI-DO, KR
9612124	AIR WATER REALIZE INC.	IWAKI-SHI Fukushima, JP
3000247873	NIPRO CORPORATION	Settsu Osaka, JP
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US
9611446	NIPRO MEDICAL INDUSTRIES LTD.	TATEBAYASHI-SHI Gunma, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009560600. Last updated year: 2026. Please use registration number 3009560600 when referencing this establishment in official correspondence.