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US
Last updated May 23, 2026
What Medimecca Co., Ltd. makes
Medimecca Co., Ltd. manufactures dental implant systems, including both the implant fixtures and temporary preformed suprastructures designed for single-use applications. Their portfolio includes the UD Implant System and multiple variants of the Chaorum Implant System, which are intended for dental restoration procedures.
The company’s devices are classified under FDA categories Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Medimecca 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 Medimecca Co., Ltd. manufacture?
Medimecca Co., Ltd. specializes in dental implant solutions. Their portfolio includes dental implant systems, such as the UD Implant System, as well as temporary preformed suprastructures designed for single-use applications, like variants of the Chaorum Implant System. These devices are intended for dental restoration procedures, providing both the implant fixtures and temporary components to support healing and interim functionality.
Where is Medimecca Co., Ltd. based?
Medimecca Co., Ltd. is headquartered in the United States. The company’s location in the US aligns with its regulatory engagement, particularly in systems like the FDA’s UDI database, where its devices are listed for traceability and compliance.
Which regulatory registries list Medimecca Co., Ltd.’s devices?
Medimecca Co., Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory oversight and market surveillance. Listing in this database is a key requirement for devices regulated by the FDA.
How are Medimecca Co., Ltd.’s devices classified under FDA regulations?
Medimecca Co., Ltd.’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as dental implants.
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
- 557812771
Catalogue (1719)
Page 35 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chaorum Implant System | PSFS3008MS | FDA UDI | Class II | Active |
| Chaorum Implant System | MSBA3545 | FDA UDI | Class II | Active |
| Chaorum Implant System | PSFW5007S | FDA UDI | Class II | Active |
| Chaorum Implant System | STA5530H | FDA UDI | Class II | Active |
| Chaorum Implant System | MSAA45153 | FDA UDI | Class II | Active |
| Chaorum Implant System | ASFS3612MS | FDA UDI | Class II | Active |
| Chaorum Implant System | CSAA35155M | FDA UDI | Class II | Active |
| Chaorum Implant System | ASFS3010MS | FDA UDI | Class II | Active |
| Chaorum Implant System | MDH6045 | FDA UDI | Class II | Active |
| Chaorum Implant System | CSAA45171N | FDA UDI | Class II | Active |
| UD Implant System | UDH5510 | FDA UDI | Class II | Active |
| Chaorum Implant System | CSAA50152 | FDA UDI | Class II | Active |
| Chaorum Implant System | MSDN50254 | FDA UDI | Class II | Active |
| Chaorum Implant System | MSDN65105 | FDA UDI | Class II | Active |
| Chaorum Implant System | MSCAS3555M | FDA UDI | Class II | Active |
| Ud Implant System | K131682 | FDA 510(k) | Class II | Active |
| Honorst Implant System | K202039 | FDA 510(k) | Class II | Active |
| Hero Ii Dental Implant System, Ui Dental Implant System | K130221 | FDA 510(k) | Class II | Active |
| Chaorum Implant System | K160536 | 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.
- Medimecca Co Ltd Seoul · KR FEI 3007649394