Data / Medical devices / Vietnam / Belmont Manufacturing Co., Ltd.
Belmont Manufacturing Co., Ltd.: FDA-registered device maker in Dong Nai, Vietnam, 2 510(k) clearances
Belmont Manufacturing Co., Ltd. is registered with the FDA (registration 3009774128) in Dong Nai, Vietnam. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 22, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009774128
- Address
- Lot I-2, Long Duc Industrial Park Binh An Ward, Dong Nai, Vietnam, [no pcode]
- 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, Evogue Dental Unit, X-Calibur Unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | 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 |
|---|---|---|---|---|---|---|
| January 22, 2016 | K152100 | Evogue Dental Unit | EIA | Substantially Equivalent | Takara Belmont Corporation | accessdata.fda.gov |
| May 17, 2000 | K000799 | BELMONT UNIT, MODEL 2000 SERIES | EIA | Substantially Equivalent | Belmont Equipment Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Light, Operating, Dental
- All makers of Chair, Dental, Without Operative Unit
Updated January 22, 2016. 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.