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Sign in to claim this brandTAKARA BELMONT CORP.
US
Last updated May 24, 2026
What TAKARA BELMONT CORP. makes
Takara Belmont Corp. manufactures dental delivery systems, including the Evogue and Quolis series for intraoral procedures, as well as stationary intraoral and panoramic dental X-ray systems like the Belmont X-Calibur Unit. Their portfolio also includes electric dental and general examination chairs, such as the Quolis Q5000 and 5000 Series models, alongside reflective and LED dental room lights like the Bel-Halo and CLESTA series.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. They appear in the FDA’s 510(k) and UDI registries, reflecting their authorised status for dental equipment. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Takara Belmont Corp. manufacture?
Takara Belmont Corp. specializes in dental equipment, including dental delivery systems like the Evogue and Quolis series for intraoral procedures, stationary intraoral and panoramic X-ray systems such as the Belmont X-Calibur Unit, electric dental chairs (e.g., Quolis Q5000 and 5000 Series), and dental room lighting solutions like the Bel-Halo and CLESTA LED series. Their portfolio focuses on tools and systems used in dental clinics for imaging, treatment, and patient care.
Where is Takara Belmont Corp. based, and how does that affect its regulatory oversight?
Takara Belmont Corp. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies most of their products as either Class I (generally low-risk) or Class II (moderate-risk requiring special controls), ensuring compliance with U.S. medical device regulations. This classification determines the authorisation process, such as 510(k) premarket notifications for higher-risk devices.
Which regulatory registries list Takara Belmont Corp.’s devices, and why?
Takara Belmont Corp.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identifier) registries. The 510(k) registry includes devices requiring premarket submissions to demonstrate substantial equivalence to a predicate device, while the UDI system ensures traceability and transparency in the supply chain. These registries reflect the company’s compliance with U.S. requirements for authorised dental equipment.
How are Takara Belmont Corp.’s devices classified under FDA regulations?
The FDA categorizes Takara Belmont Corp.’s devices primarily as Class I (low-risk, often exempt from strict premarket controls) or Class II (moderate-risk, requiring special controls like performance standards or post-market surveillance). For example, dental chairs and lighting systems may fall into Class I, while X-ray systems or advanced delivery units could be Class II due to their role in patient safety and diagnostic accuracy. Classification determines the regulatory pathway for authorisation.
Why might a dental clinic need to verify Takara Belmont Corp.’s device listings in regulatory databases?
Clinics should verify listings in the FDA’s 510(k) and UDI registries to confirm a device’s authorised status, ensuring it meets U.S. safety and performance standards before use. This step helps avoid legal or operational risks, as only devices with valid registrations (e.g., cleared 510(k)s or properly assigned UDIs) are legally marketable. It also supports compliance with healthcare facility accreditation requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- belmonteqip.com
- —
- —
- [email protected]
- Phone
- 732 4695000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 690540349
Catalogue (113)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Belmax Cm | BELMAX(L) | FDA UDI | Class II | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| Belcypher Pro | BELCYPHER PRO | FDA UDI | Class II | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| PHOT-X IIs Model 505 | 505 | FDA UDI | Class II | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| PHOT-X IIs Model 505 | 505 | FDA UDI | Class II | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Bel-Halo LED | Bel-Halo LED | FDA UDI | Class I | Active |
| Bel-Halo LED | Bel-Halo LED | FDA UDI | Class I | Active |
| Belray Ii | 097 | FDA UDI | Class II | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Belmont X-Calibur Unit | AU-XV2500CVR | FDA UDI | Class I | Active |
| Clesta Led Dental Light | AL-320X | FDA UDI | Class I | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Belmont Equipment (Chair) | Belmont Equipment (Chair) | FDA UDI | Class I | Active |
| Clesta Led Dental Light | AL-301R-NA | FDA UDI | Class I | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| Bel-Halo LED | Bel-Halo LED | FDA UDI | Class I | Active |
| PHOT-X IIs Model 505 | 505 | FDA UDI | Class II | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Dg-770-Rst | AW-G091X | FDA UDI | Class I | Active |
| Evogue Chair | AC-Q33-CD36US | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| PHOT-X IIs Model 505 | 505 | FDA UDI | Class II | Active |
| Bel-Halo Dental Light | AL-D241W-NA | FDA UDI | Class I | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Evogue Dental Unit | AU-HV3401W | FDA UDI | Class I | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Belray Ii | 097 | FDA UDI | Class II | Active |
| PHOT-X IIs Model 505 | 505 | FDA UDI | Class II | Active |
| Evogue Dental Unit | Evogue Dental Unit | FDA UDI | Class I | Active |
| Bel-Halo Dental Light | AL-D249W-X | FDA UDI | Class I | Active |
| Evogue Dental Unit | AU-HV3420C-US | FDA UDI | Class I | Active |
| Clesta Led Dental Light | AL-302C-NA-PN | FDA UDI | Class I | Active |
| Proiii 047 | AC-47R-FD36US | FDA UDI | Class I | Active |
| Clesta Led Dental Light | AL-320XC | FDA UDI | Class I | Active |
| Quolis Chair | AC-Q55-CD36US | FDA UDI | Class I | Active |
| Belmont X-Calibur Unit | Belmont X-Calibur Unit | FDA UDI | Class I | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| Bel-Nova LED | Bel-Nova LED | FDA UDI | Class I | Active |
| PHOT-X IIs Model 505 | 505 | FDA UDI | Class II | Active |
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