Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010972172

FEI Number

3010972172

Entity Name

Takara Medical Co., Ltd.

City/State/Country

Amagasaki Hyogo, JP

Establishment Address

5-15, Nukata-cho, Amagasaki Hyogo 661-0962, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

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

097 Bel-Ray II PHOT-X II, MODEL 303

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2010-03-30
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2010-03-30
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
9611445	TAKARA BELMONT CORPORATION	OSAKA, JP
3014766731	TAKARA BELMONT CORPORATION, OSAKA FACTORY	OSAKA, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
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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3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010972172. Last updated year: 2026. Please use registration number 3010972172 when referencing this establishment in official correspondence.