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Sign in to claim this brandTOKYO GIKEN INC.
US
Last updated May 23, 2026
What TOKYO GIKEN INC. makes
Tokyo Giken Inc. manufactures dental suction systems, including fixed and free-arm models designed for oral healthcare procedures. Their portfolio includes both wall-mounted and portable units, each configured for specific voltage requirements (120V). These devices are primarily used in dental clinics to manage fluids during treatments.
The company’s dental suction systems are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The products are intended for use in the United States, adhering to applicable regulatory standards for low-risk devices.
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 Tokyo Giken Inc. manufacture?
Tokyo Giken Inc. specializes in dental suction systems, which are used in oral healthcare settings to manage fluids during dental procedures. These systems include both fixed (wall-mounted) and free-arm (portable) models, such as the TCV-FAC series and the arteo series, designed for specific voltage requirements like 120V. Their focus is on devices that assist in maintaining a clean workspace during treatments.
Where is Tokyo Giken Inc. based, and where are their devices intended for use?
Tokyo Giken Inc. is based in the United States. Their dental suction systems are specifically designed and intended for use within the U.S. market, adhering to regulatory standards applicable to that jurisdiction.
Which regulatory registries list Tokyo Giken Inc.’s devices?
Tokyo Giken Inc.’s dental suction systems are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class I devices, ensuring transparency and compliance with U.S. regulatory requirements for low-risk medical products.
How are Tokyo Giken Inc.’s dental suction systems classified under U.S. regulations?
Tokyo Giken Inc.’s dental suction systems fall under Class I classification according to FDA regulations. This classification is assigned to devices that pose minimal risk to patients and typically require less stringent premarket review, as they are considered low-risk. The classification is based on factors like the device’s intended use, potential harm, and design complexity.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 692497670
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tcv-Fac-21s(sbf)(23060) | W131 | FDA UDI | Class I | Active |
| Tcv-Fac-21s(sbf)(46060) | W133 | FDA UDI | Class I | Active |
| Tcv-Fac-21w(sbf)(46060) | W134 | FDA UDI | Class I | Active |
| Tcv-Fac-21w(sbf)(23060) | W132 | FDA UDI | Class I | Active |
| Free arm arteo-S(120V) | W098 | FDA UDI | Class I | Active |
| Free arm arteo-I(120V) | W129 | FDA UDI | Class I | Active |
| Free arm arteo-F(120V) | W128 | FDA UDI | Class I | Active |
| Free arm arteo-T(120V) | W130 | FDA UDI | Class I | Active |
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