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Sign in to claim this brandDentium Co., Ltd.
US
Last updated May 24, 2026
What Dentium Co., Ltd. makes
Dentium Co., Ltd. manufactures dental implant suprastructures, including permanent and temporary preformed types, as well as two-piece screw endosteal dental implants. Their portfolio also includes reusable dental surgical kits, drill bits, manual instrument handles, soft-tissue punches, and digital panoramic/tomographic X-ray systems for dental use.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Dentium Co., Ltd. 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 Dentium Co., Ltd. primarily manufacture?
Dentium Co., Ltd. specializes in dental devices, including permanent and temporary preformed dental implant suprastructures, two-piece screw endosteal dental implants, and reusable surgical kits for dental procedures. Their portfolio also covers reusable dental tools like drill bits, manual instrument handles, soft-tissue punches, and digital panoramic/tomographic X-ray systems. These products focus on dental restoration, surgical support, and diagnostic imaging.
Where is Dentium Co., Ltd. based, and how does this affect its regulatory oversight?
Dentium Co., Ltd. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies their products as either Class I (generally low-risk) or Class II (requiring special controls to ensure safety and effectiveness), depending on the specific device and its intended use. This classification determines the regulatory pathway for authorization.
Are Dentium Co., Ltd.’s devices listed in any regulatory registries, and why does this matter?
Yes, Dentium Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and manufacturers to track devices throughout their lifecycle. Listing in the UDI database is a requirement for Class II devices and helps streamline post-market surveillance and compliance efforts.
How are Dentium Co., Ltd.’s dental implant devices classified under FDA regulations?
Dentium Co., Ltd.’s dental implant devices, such as their two-piece screw endosteal implants and suprastructures, are classified under FDA’s Class I or Class II categories. Class II classification applies to implants due to their role in supporting critical bodily functions (e.g., chewing) and the need for special controls to mitigate risks like infection or improper placement. This classification ensures rigorous evaluation before authorization.
What kinds of dental imaging equipment does Dentium Co., Ltd. produce, and how does it fit into their broader product line?
Dentium Co., Ltd. manufactures stationary panoramic/tomographic dental X-ray systems, which are digital imaging devices used for capturing detailed 3D images of a patient’s jaw, teeth, and surrounding structures. These systems complement their broader product line by providing diagnostic tools for planning dental implant procedures, assessing bone structure, and monitoring treatment progress. Like their other devices, they are designed for dental professionals.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dentiumusa.com
- —
- —
- [email protected]
- Phone
- +1(714)226-0229
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689514395
Catalogue (2418)
Page 49 of 49| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dentium Implantium & SuperLine Prosthetics | K172640 | FDA 510(k) | Class II | Active |
| Speedy Orthodontic Screw | K060500 | FDA 510(k) | Class II | Active |
| Implantium Prosthetics | K070228 | FDA 510(k) | Class II | Active |
| Dentium Co., Ltd. Implantium | K041368 | FDA 510(k) | Class II | Active |
| Dentium Ti-Base | K171622 | FDA 510(k) | Class II | Active |
| Dentium CAD/CAM Abutments | K161713 | FDA 510(k) | Class II | Active |
| Dentium NR Line CAD/CAM Abutments | K170384 | FDA 510(k) | Class II | Active |
| Implantium II | K171126 | FDA 510(k) | Class II | Active |
| Scan Abutments and Comfort Caps | K191634 | FDA 510(k) | Class II | Active |
| Burn-out Cylinder and Angled Screw Abutments | K160483 | FDA 510(k) | Class II | Active |
| Dentium Implantium And Superline Abutments | K141457 | FDA 510(k) | Class II | Active |
| Slim Onebody System | K111162 | FDA 510(k) | Class II | Active |
| Implantium Ii | K060501 | FDA 510(k) | Class II | Active |
| Implantium Abutments | K052823 | FDA 510(k) | Class II | Active |
| Implantium Prosthetics | K052957 | FDA 510(k) | Class II | Active |
| SuperLine | K213599 | FDA 510(k) | Class II | Active |
| Simpleline Ii Model Sofx483408r, Sofx483410r Total 44 Models | K102308 | FDA 510(k) | Class II | Active |
| Healing Abutments and Cover Screws | K192436 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dentium Co., Ltd. Suwon-si Gyeonggi · KR FEI 3004578807