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Sign in to claim this brandWhat Truabutment Korea Co., Ltd makes
Truabutment Korea Co., Ltd manufactures intraoral-scanning dental implant abutment analogs, including single-use and reusable versions, alongside reusable surgical procedure kits for dental/maxillofacial procedures. Their portfolio also includes reusable surgical screwdrivers designed for precision in dental applications, as well as specialized pylon anchor kits for implant systems.
All listed devices fall under Class I regulatory classification and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
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 Truabutment Korea Co., Ltd primarily manufacture?
Truabutment Korea Co., Ltd specializes in dental devices, including intraoral-scanning dental implant abutment analogs (both single-use and reusable), reusable dental/maxillofacial surgical procedure kits, and reusable surgical screwdrivers. Their product line also includes specialized pylon anchor kits for dental implant systems, all designed for precision in dental and maxillofacial applications.
Where is Truabutment Korea Co., Ltd based, and how does this affect its devices?
Truabutment Korea Co., Ltd is based in the United States, meaning its devices are subject to U.S. medical device regulations. This includes compliance with FDA requirements, such as registration in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and regulatory oversight for its products.
Which regulatory registries list devices manufactured by Truabutment Korea Co., Ltd?
Devices from Truabutment Korea Co., Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and compliance with regulatory standards.
How are the devices produced by Truabutment Korea Co., Ltd classified under U.S. regulations?
All devices manufactured by Truabutment Korea Co., Ltd fall under Class I regulatory classification in the U.S. This classification applies to low-risk devices, such as dental implant analogs, surgical kits, and screwdrivers, which are deemed to pose minimal risk to patients when used as intended.
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
- 694514760
Catalogue (106)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surgical Plus Kit | SPK01 | FDA UDI | Class I | Active |
| Pylon Crestal Sinus Kit | PSK01 | FDA UDI | Class I | Active |
| TruScan body | SBR-MSB | FDA UDI | Class I | Active |
| TruScan body | SBS-MSB | FDA UDI | Class I | Active |
| TruScan body | BH35-MSB | FDA UDI | Class I | Active |
| TruScan body | NAN-MSB | FDA UDI | Class I | Active |
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