FDA Registration
Active
🇯🇵 Japan
TAKARA BELMONT CORPORATION
Reg #: 9611445
·
FEI: 3002808310
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- TAKARA BELMONT CORPORATION
- Registration Number
- 9611445
- FEI Number
- 3002808310
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2-1-1, HIGASHISHINSAIBASHI, CHUO-KU
- City
- OSAKA
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K072273
Owner / Operator
- Firm Name
- TAKARA BELMONT CORPORATION
- Operator Number
- 8031613
- Address
- 2-1-1, HIGASHISHINSAIBASHI, CHUO-KU
- City
- OSAKA
- State
- JP-27
- Postal Code
- 542-0083
- Country
- JP
- Correspondent
- HITOMI - TOKUDA
US Agent
- Business Name
- TAKARA BELMONT USA, INC.
- Contact Name
- Gary Stern
- Address
- 101 Belmont Dr
- City
- Somerset
- State
- NJ
- ZIP
- 08873
- Country
- US
- [email protected]
- Phone
- 732 4695000 ext. 1155
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2016-01-28 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2008-11-06 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2015-02-18 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2010-03-30 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 1994-10-14 |
| Chair, Surgical, Ac-Powered | GBB | Class 1 | General, Plastic Surgery | No | 2018-12-28 |
Proprietary Names
Belmont Equipment
QUOLIS 5000 SERIES DENTAL UNIT
PHOT-X-IIS Model 505
PHOT-X II, MODEL 303
097 Bel-Ray II
Belmont
DG-770 series (DG-770-RST, DG-770-FST, DG-770-F)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility