Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611445

FEI Number

3002808310

Entity Name

TAKARA BELMONT CORPORATION

City/State/Country

OSAKA, JP

Establishment Address

2-1-1, HIGASHISHINSAIBASHI, CHUO-KU, OSAKA 542-0083, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TAKARA BELMONT CORPORATION (Owner Number: 8031613)

Owner / Operator Contact Address

2-1-1, HIGASHISHINSAIBASHI, CHUO-KU, OSAKA, JP-27 542-0083, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042260

PMA Number

N/A

All Registered Proprietary Names

Belmont Equipment QUOLIS 5000 SERIES DENTAL UNIT PHOT-X-IIS Model 505 PHOT-X II, MODEL 303

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2016-01-28
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2008-11-06
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2015-02-18
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	1994-10-14

Official Correspondent

HITOMI TOKUDA

US Agent Details

Gary Stern Business: TAKARA BELMONT USA, INC. Email: regulatory@takarabelmont.com Phone: (732) 4695000

Related Public Records

Same Entity

TAKARA BELMONT CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017937246	TAKARA BELMONT CORPORATION,SHIGA EQUIPMENT FACTORY	KONAN Shiga, JP
3029972406	BELMONT TECHNO KYOTO CORPORATION	Yawata Kyoto, JP
3009774128	Belmont Manufacturing Co., Ltd.	Long Thanh District Dong Nai, VN
3014766731	TAKARA BELMONT CORPORATION, OSAKA FACTORY	OSAKA, JP
3010972172	Takara Medical Co., Ltd.	Amagasaki Hyogo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611445. Last updated year: 2026. Please use registration number 9611445 when referencing this establishment in official correspondence.