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Sign in to claim this brandWhat ZOGEAR Medical Co., Ltd. makes
ZOGEAR Medical Co., Ltd. manufactures single-use dental impression material syringes designed for precision in endodontic procedures. Their product line includes color-coded syringes tailored for consistent material delivery in root canal treatments. These devices are intended for disposable use to ensure sterility and reduce cross-contamination in clinical settings.
The company’s dental impression material syringes fall under Class I regulatory classification in the US. These devices are listed in the FDA’s UDI (Unique Device Identification) database, adhering to mandatory identification requirements for medical devices. The manufacturer operates from 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 ZOGEAR Medical Co., Ltd. manufacture?
ZOGEAR Medical Co., Ltd. specializes in single-use dental impression material syringes. These devices are specifically designed for endodontic procedures, such as root canal treatments, to deliver dental impression material with precision. The syringes are color-coded to enhance usability and ensure consistent material delivery in clinical settings.
Where is ZOGEAR Medical Co., Ltd. based?
ZOGEAR Medical Co., Ltd. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Are ZOGEAR Medical Co., Ltd.’s devices listed in any regulatory registries?
Yes, ZOGEAR Medical Co., Ltd.’s dental impression material syringes are listed in the FDA’s Unique Device Identification (UDI) database. This registry is mandatory for Class I devices in the US, ensuring traceability and compliance with identification requirements for medical devices.
How are ZOGEAR Medical Co., Ltd.’s devices classified under US regulations?
ZOGEAR Medical Co., Ltd.’s dental impression material syringes are classified as Class I devices under US regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as single-use syringes for dental impression materials. The classification determines the regulatory pathway for authorization.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 710958353
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CanalPro Color Syringes | CanalPro Color Syringes (10 ml) white | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (5 ml) red | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (5 ml) blue | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (10 ml) red | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (10 ml) blue | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (5 ml) yellow | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (5 ml) white | FDA UDI | Class I | Active |
| CanalPro Color Syringes | CanalPro Color Syringes (10 ml) yellow | FDA UDI | Class I | Active |
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