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Sign in to claim this brandWhat GUANGZHOU HEYGEARS IMC.INC makes
The company produces resin-based dental materials for temporary crowns and bridges, denture teeth, and dental appliance fabrication. These include UV-curable resins designed for quick fabrication of temporary restorations and prosthetic components, such as artificial teeth and bridge frameworks.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. 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 Guangzhou Heygears IMC, Inc. manufacture?
Guangzhou Heygears IMC, Inc. specializes in resin-based dental materials. Their portfolio includes temporary dental crowns and bridges, artificial teeth for dentures, and resins used for fabricating dental appliances. These materials are designed for quick, UV-curable fabrication of temporary restorations and prosthetic components.
Where is Guangzhou Heygears IMC, Inc. based?
The company operates from the United States. While its name suggests a Chinese origin, its manufacturing and business activities are conducted within the US market.
Which regulatory registries list devices manufactured by Guangzhou Heygears IMC, Inc.?
All devices produced by Guangzhou Heygears IMC, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for their resin-based dental products.
How are the devices from Guangzhou Heygears IMC, Inc. classified under FDA regulations?
The company’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential health impact.
What is the primary purpose of the resin materials produced by Guangzhou Heygears IMC, Inc.?
The resins produced by Guangzhou Heygears IMC, Inc. are primarily designed for temporary dental applications, such as fabricating crowns, bridges, and denture teeth. These UV-curable materials enable quick and precise production of restorations, reducing chair time for dental professionals while maintaining functional and aesthetic standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- heygears.com
- —
- —
- [email protected]
- Phone
- +8602089857621
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 418561545
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