Registered with FDA

Toyo Medical Co.

Miami, FL, United States. Lists 18 dental device types with FDA across 1 registered establishment.

FDA owner/operator9000332Repacker / relabeler

Device types listed: 18
Brands and models: 25
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1United States

Devices listed with FDA

What Toyo Medical Co. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Handpiece and Cord Foot ControllerEBW · Class 1	—	Lister	TOYO MEDICAL CO	2011
Extraoral with Timer X-Ray UnitEHD · Class 2	Dental X-ray units	Lister	Takara Belmont CoTakara Belmont CorporationTOYO MEDICAL COToyo Medical Co.	2011
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Lister	nakanishiTOYO MEDICAL CO	2011
Digital Extraoral Source X-Ray SystemMUH · Class 2	Dental X-ray units	Lister	Takara Belmont CoToyo Medical Co.	2011
Endodontic Pulp Canal ReamerEKP · Class 1	Endodontic files	Lister	TOYO MEDICAL CO	2011
Ac-Powered Direct Drive HandpieceEKX · Class 1	Dental handpieces	Lister	TOYO MEDICAL CO	2011
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Lister	Nakanishi IncNakanishi Inc.	2011
Accessories Operative Dental UnitNRD · Class 1	—	Lister	Takara Belmont CompanyTOYO MEDICAL CO	2011
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Lister	TOYO MEDICAL CO	2011
Powered Bone DrillDZI · Class 2	Surgical drills & motors	Lister	Nakanishi Inc.	2018
Dental Diamond InstrumentDZP · Class 1	Dental burs & diamonds	Lister	TOYO MEDICAL CO	2012
Dental Operating LightEAZ · Class 1	Dental operating lights	Lister	Toyo Medical Co	2013
Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1	Dental handpieces	Lister	Nakanishi Inc	2011
Operative Dental UnitEIA · Class 1	Dental chairs & operative units	Lister	Toyo Medical Co.	2013
Dental BurEJL · Class 1	Dental burs & diamonds	Lister	TOYO MEDICAL CO	2011
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Lister	TOYO MEDICAL CO.	2013
Rotary Bone Cutting HandpieceKMW · Class 2	Surgical drills & motors	Lister	TOYO MEDICAL CO	2011
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2	Intraoral scanners	Lister	Planmeca Oy	2024

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

Also lists devices cleared under other names

Toyo Medical Co. 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: Nsk Nakanishi, Inc. (9), Nakanishi, Inc. (4), Takara Belmont Corporation (2), Takara Belmont USA, Inc. (2), Instrumentarium Dental, Palodex Group OY (1), Soredex Palodex Group OY (1), Belmont Equipment Corp. (1), The Hygenic Company, LLC (1).

Decided	510(k)	Device	Applicant	Device type
3 Sep 2014	K141293	PHOT-X IIS MODEL 505	Takara Belmont Corporation	EHD Extraoral with Timer X-Ray Unit
6 Oct 2010	K093683	ORTHOPANTOMOGRAPH OP300	Instrumentarium Dental, Palodex Group OY	MUH Digital Extraoral Source X-Ray System
22 Mar 2010	K093240	BELRAY II	Takara Belmont Corporation	EHD Extraoral with Timer X-Ray Unit
21 Jan 2009	K081811	CARE3 PLUS	Nakanishi, Inc.	EFB Dental Air-Powered Handpiece
10 Jul 2008	K073678	VARIOSURG	Nakanishi, Inc.	DZI Powered Bone Drill
20 Dec 2007	K072273	BELMONT QUOLIS 5000 SERIES DENTAL UNIT	Takara Belmont USA, Inc.	NRD Accessories Operative Dental Unit
7 Sep 2004	K042260	PHOT-X II, MODEL 303	Takara Belmont USA, Inc.	EHD Extraoral with Timer X-Ray Unit
15 Jun 2004	K041050	DIGORA OPTIME (OR DIGORA ONTIME)	Soredex Palodex Group OY	MUH Digital Extraoral Source X-Ray System
8 Apr 2002	K020327	SURGIC IV IMPLANT CONTROL UNIT	Nakanishi, Inc.	EBW Handpiece and Cord Foot Controller
11 Sep 2001	K011926	ELEC-MATE E	Nakanishi, Inc.	EBW Handpiece and Cord Foot Controller
23 Jun 1999	K991021	SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL	Nsk Nakanishi, Inc.	ELC Ultrasonic Scaler
9 Jun 1999	K990954	ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET	Nsk Nakanishi, Inc.	EBW Handpiece and Cord Foot Controller
24 Mar 1999	K990682	PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)	Nsk Nakanishi, Inc.	EKX Ac-Powered Direct Drive Handpiece
19 Mar 1999	K990646	PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE	Nsk Nakanishi, Inc.	EKX Ac-Powered Direct Drive Handpiece
12 Jan 1999	K983661	BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES	Belmont Equipment Corp.	EIA Operative Dental Unit
30 Oct 1997	K972924	SURGIC II IMPLANT CONTROL UNIT	Nsk Nakanishi, Inc.	EBW Handpiece and Cord Foot Controller
15 Apr 1997	K970953	E-TYPE SPEED REDUCER CONTRA ANGLE	Nsk Nakanishi, Inc.	KMW Rotary Bone Cutting Handpiece
24 Sep 1996	K962542	AIR MOTOR HANDPIECE TN-102	Nsk Nakanishi, Inc.	EFB Dental Air-Powered Handpiece
12 Sep 1996	K962540	E-TYPE CONTRA ANGLE NAC-E	Nsk Nakanishi, Inc.	EGS Dental Contra- and Right-Angle Attachment Handpiece
11 Sep 1996	K962543	ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU	Nsk Nakanishi, Inc.	EFB Dental Air-Powered Handpiece
25 Jul 1991	K905418	GATES GLIDDEN DRILLS	The Hygenic Company, LLC	DZA Intraoral Dental Drill
11 Aug 1989	K893844	3D DENTAL DIAMOND ROTARY INSTRUMENTS	Lustgarten Multi-Tech International, Inc.	DZP Dental Diamond Instrument
5 Apr 1977	K770598	ENDODONTIC INSTRUMENTS, R&R CUTWELL	Ransom & Randolph. LLC.	EKP Endodontic Pulp Canal Reamer

Registered establishments

Establishment	Location	What it does
TOYO MEDICAL CO.FDA reg. 1054713	Doral, FL, United States	Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9000332). 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.