Manufacturer registered with FDA

Nakamura Dental Handpiece Mfg. Co., Ltd.

TOKYO, Japan. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9010791Contract manufacturerManufacturer
Device types listed
2
Brands and models
17
510(k) clearances
12012–2012
Markets registered in
1United States
Establishments
1Japan
2012: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Nakamura Dental Handpiece Mfg. Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1Dental handpiecesMaker
ACCLEANCONTRA ANGLEHyGenieNDProphy SportProphyProQuality PlusTT(Turbo Torque)1000 Highspeed Airturbine HandpieceXpro
2008
Dental Air-Powered HandpieceEFB · Class 1Dental handpiecesMaker
ACCLEANHyGenieNDProphy SportProphyProQuality PlusTT(Turbo Torque)1000 Highspeed Airturbine HandpieceXpro
2008

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Nakamura Dental Handpiece Mfg. Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
23 Feb 2012K113222ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECEEFB Dental Air-Powered Handpiece

Also lists devices cleared under other names

Nakamura Dental Handpiece Mfg. Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Nakamura Magnifier Co., Ltd. (1).

Decided510(k)DeviceApplicantDevice type
20 Mar 2008K073652ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLENakamura Magnifier Co., Ltd.EFB Dental Air-Powered Handpiece

Registered establishments

EstablishmentLocationWhat it does
NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.FDA reg. 9614686ITABASHI-KU Tokyo, JapanContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9010791). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.