Manufacturer registered with FDA
Takara Belmont Corporation
OSAKA, Japan. Lists 6 dental device types with FDA across 5 registered establishments, and holds 7 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 72009–2017
- Markets registered in
- 15216 registrations outside the US
- Establishments
- 5Japan, Vietnam
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Takara Belmont Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Takara Belmont Corporation | 7 clearances | 2009–2017 | Below |
| Canada | Health Canada | Registration holder | TAKARA BELMONT CORPORATIONBELMONT MANUFACTURING CO., LTD. | 65 | 2004–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | TAKARA BELMONT CO., LTDTakara Medical Co., Ltd. · TAKARA BELMONT CO.LTD · +2 | 48 | 1999–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TAKARA BELMONT CORPORATION - OSAKA FACTORYTAKARA BELMONT CORPORATION · TAKARA BELMONT CORPORATION – OSAKA FACTORY · +2 | 35 | 1982–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Takara Belmont CorporationBELMONT MANUFACTURING CO., LTD.. | 18 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TAKARA BELMONT CORPORATIONTAKARA MEDICAL CO., LTD · BELMONT MANUFACTURING COMPANY LIMITED · +2 | 14 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Takara Belmont Corporation | 8 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Takara Belmont Corp. | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Takara Belmont Corporation | 5 | 2020–2024 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Takara Belmont Corporation | 5 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | TAKARA BELMONT CORPORATION | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Belmont Manufacturing CO., LTDTakara Belmont Corporation | 2 | 2015–2015 | Pure Global AI |
| China | NMPA | Registration holder | 宝贝蒙株式会社Takara Belmont Corporation贝蒙制造有限公司Belmont Manufacturing Co., Ltd | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TAKARA BELMONT CORPORATIONTAKARA MEDICAL CO. LTD. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TAKARA MEDICAL CO., LTD. | 1 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Takara Belmont Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | PHOT-X II, MODEL 303PHOT-X-IIS Model 505097 Bel-Ray II | 1994 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Belmont | 1994 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Belmont Equipment | 2016 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | BelmontEvogue Dental UnitX-Calibur Unit | 2007 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | 097 Bel-Ray II | 2010 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | QUOLIS 5000 SERIES DENTAL UNIT | 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 Takara Belmont Corporation as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Mar 2017 | K163175 | Bel-Cypher Pro | MUH Digital Extraoral Source X-Ray System |
| 22 Jan 2016 | K152100 | Evogue Dental Unit | EIA Operative Dental Unit |
| 3 Sep 2014 | K141293 | PHOT-X IIS MODEL 505 | EHD Extraoral with Timer X-Ray Unit |
| 19 Jul 2011 | K101181 | BEL-CAT | OAS Dental Computed Tomography X-Ray |
| 17 Feb 2011 | K110160 | BEL-CYPHER N | MUH Digital Extraoral Source X-Ray System |
| 22 Mar 2010 | K093240 | BELRAY II | EHD Extraoral with Timer X-Ray Unit |
| 13 Mar 2009 | K090020 | BEL-CYPHER, MODEL Y977 | MUH Digital Extraoral Source X-Ray System |
Also lists devices cleared under other names
Takara Belmont Corporation 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: Takara Belmont USA, Inc. (2), Belmont Equipment Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 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 |
| 17 May 2000 | K000799 | BELMONT UNIT, MODEL 2000 SERIES | Belmont Equipment Corp. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Belmont Manufacturing Co., Ltd.FDA reg. 3009774128 | Dong Nai, Vietnam | Complaint file establishment, Manufacturer |
| BELMONT TECHNO KYOTO CORPORATIONFDA reg. 3029972406 | Yawata Kyoto, Japan | Contract manufacturer |
| TAKARA BELMONT CORPORATIONFDA reg. 9611445 | OSAKA, Japan | Complaint file establishment, Specification developer |
| TAKARA BELMONT CORPORATION, OSAKA FACTORYFDA reg. 3014766731 | OSAKA, Japan | Complaint file establishment, Manufacturer |
| Takara Medical Co., Ltd.FDA reg. 3010972172 | Amagasaki Hyogo, Japan | Complaint file establishment, Manufacturer |
Other names on FDA records
Belmont Manufacturing Co., Ltd · Takara Medical Co., Ltd. · Takara Belmont Corporation – Osaka Factory · Belmont Techno Kyoto Corporation
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8031613). 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.