Data / Medical devices / Japan / Takara Belmont Corporation
Takara Belmont Corporation: FDA-registered device maker in Osaka, Japan, 4 510(k) clearances
Takara Belmont Corporation is registered with the FDA (registration 9611445) in Osaka, Japan. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 3, 2014. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9611445
- FEI number
- 3002808310
- Address
- 2-1-1, Higashishinsaibashi Chuo-Ku, Osaka, Japan, 542-0083
- Owner or operator
- TAKARA BELMONT CORPORATION (8031613)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 14, 1994
- Registered through
- 2027
- Brand names listed
- 097 Bel-Ray II, Belmont, Belmont Equipment, DG-770 series (DG-770-RST, DG-770-FST, DG-770-F), PHOT-X II, MODEL 303, PHOT-X-IIS Model 505, QUOLIS 5000 SERIES DENTAL UNIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chair, Surgical, Ac-Powered | GBB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 3, 2014 | K141293 | PHOT-X IIS MODEL 505 | EHD | Substantially Equivalent | Takara Belmont Corporation | accessdata.fda.gov |
| March 22, 2010 | K093240 | BELRAY II | EHD | Substantially Equivalent | Takara Belmont Corp. | accessdata.fda.gov |
| December 20, 2007 | K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | NRD | Substantially Equivalent | Takara Belmont USA, Inc. | accessdata.fda.gov |
| September 7, 2004 | K042260 | PHOT-X II, MODEL 303 | EHD | Substantially Equivalent | Takara Belmont USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Surgical, Ac-Powered
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Light, Operating, Dental
- All makers of Chair, Dental, Without Operative Unit
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Unit, Operative Dental, Accessories
Updated September 3, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.