Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010373292

FEI Number

3010373292

Entity Name

TAIYO KOGYO CO., LTD. HANYU TECHNICAL PLANT

City/State/Country

Hanyu Saitama, JP

Establishment Address

2-45 Ohnuma, Hanyu Saitama 348-0016, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TAIYO KOGYO CO., LTD. HANYU TECHNICAL PLANT (Owner Number: 10086964)

Owner / Operator Contact Address

2-45 Ohnuma, Hanyu, JP-11 348-0016, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VA370 VA370LUXADNA VA370ADNA VA370 Lux VA370LUXNA VA370NA VA970 120V Varios 970 Unit NA VA970 LUX 120V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2022-12-27
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2022-12-27

Official Correspondent

Junghee Kim

US Agent Details

SEAN KAUFMAN Business: NSK AMERICA CORPORATION Email: nskra@nsk-nakanishi.co.jp Phone: (888) 6751675

Related Public Records

Same Entity

TAIYO KOGYO CO., LTD. HANYU TECHNICAL PLANT

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
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

Similar Registrations

Registration Number	Establishment Name	Location
3042256012	QUANZHOU AGURU E-COMMERCE CO., LTD	Quanzhou Fujian, CN
1052939	Medidenta	Las Vegas, NV, US
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3003933619	MECTRON S.P.A.	CARASCO Genova, IT
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010373292. Last updated year: 2026. Please use registration number 3010373292 when referencing this establishment in official correspondence.