Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614686

FEI Number

3003340029

Entity Name

NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.

City/State/Country

ITABASHI-KU Tokyo, JP

Establishment Address

59-2 MINAMI-CHO, ITABASHI-KU Tokyo 173-0027, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. (Owner Number: 9010791)

Owner / Operator Contact Address

59-2 MINAMI-CHO, ITABASHI-KU, TOKYO, JP-13 173-0027, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TT(Turbo Torque)1000 Highspeed Airturbine Handpiece Xpro ACCLEAN Prophy Sport Quality Plus ProphyPro HyGenie ND

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2008-03-21
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2008-03-21
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-03-13

Official Correspondent

SHINICHI NAKAMURA

US Agent Details

Shinichi Ito Business: HEAD DENTAL CORPORATION Email: charlie@headdental.com Phone: (949) 4740176

Related Public Records

Same Entity

NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.

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
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17

Similar Registrations

Registration Number	Establishment Name	Location
3017619674	FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.	Foshan Guangdong, CN
3014683120	JMU DENTAL, INC	Fullerton, CA, US
3027234828	PREMIUM PLUS (DONGGUAN) LIMITED	Dongguan Guangdong, CN
9710363	BONART CO. LTD.	KEELUNG, TW
1223843	BICON, LLC	Boston, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614686. Last updated year: 2026. Please use registration number 9614686 when referencing this establishment in official correspondence.