Data / Medical devices / Japan / Takara Belmont Corporation, Osaka Factory
Takara Belmont Corporation, Osaka Factory: FDA-registered device maker in Osaka, Japan, 1 510(k) clearance
Takara Belmont Corporation, Osaka Factory is registered with the FDA (registration 3014766731) in Osaka, Japan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2007. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014766731
- Address
- 2-6-59, Kitatsumori, Nishinari-Ku, Osaka, Japan, 557-0061
- Owner or operator
- TAKARA BELMONT CORPORATION (8031613)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 14, 1994
- Registered through
- 2027
- Brand names listed
- Belmont, Belmont Equipment, QUOLIS 5000 SERIES DENTAL UNIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2007 | K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | NRD | Substantially Equivalent | Takara Belmont USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental, Accessories
- All makers of Chair, Dental, Without Operative Unit
- All makers of Light, Operating, Dental
Updated December 20, 2007. 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.