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Sign in to claim this brandWhat Saeshin Precision Co., Ltd. makes
Saeshin Precision Co., Ltd. manufactures dental power tools, including line-powered systems for clinical and laboratory use, as well as motorized handpieces for bone and joint surgical procedures. Their portfolio also includes reusable electric handpiece sets and an in vitro diagnostic calibrator for 5-nucleotidase assays.
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. 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 Saeshin Precision Co., Ltd. manufacture?
Saeshin Precision Co., Ltd. specializes in dental power tools, including line-powered systems for clinical and laboratory use. Their portfolio also includes motorized handpieces for bone and joint surgical procedures, reusable electric handpiece sets, and an in vitro diagnostic (IVD) calibrator for 5-nucleotidase assays. These devices are designed for precision applications in dental and orthopedic settings.
Where is Saeshin Precision Co., Ltd. based?
Saeshin Precision Co., Ltd. operates from the United States. The company’s U.S. presence is reflected in its regulatory listings and device classifications under FDA guidelines.
Which regulatory registries list Saeshin Precision Co., Ltd.’s devices?
Saeshin Precision Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized devices, including dental power tools and surgical handpieces.
How are Saeshin Precision Co., Ltd.’s devices classified under FDA regulations?
Saeshin Precision Co., Ltd.’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on factors like intended use and potential risk.
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
- 688019566
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Traus Sus10 | TRAUS MBP10SL | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #7 | FDA UDI | Class II | Active |
| Td-Auto | TD-AUTO | FDA UDI | Class I | Active |
| Traus Ssg10 | SSG10 #8 | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #3 | FDA UDI | Class II | Active |
| Traus Sus10 | TRAUS CRB27LX | FDA UDI | Class I | Active |
| Traus Ssg30 | SSG30 | FDA UDI | Class I | Active |
| X-Cube | X-CUBE | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #4 | FDA UDI | Class I | Active |
| X-Cube | ACL(B)-03F | FDA UDI | Class I | Active |
| Traus Sus10 | TRAUS CRB27XX | FDA UDI | Class I | Active |
| Traus Sus10 | TRAUS CRB26XX | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #6 | FDA UDI | Class II | Active |
| Ssg10 | SSG10 #2 | FDA UDI | Class II | Active |
| Traus Ssg10 | TRAUS BSG10 | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #10 | FDA UDI | Class II | Active |
| Traus Ssg20 | SSG20 | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #5 | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #6 | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #5 | FDA UDI | Class II | Active |
| Traus Sus10 | TRAUS FUS10 | FDA UDI | Class I | Active |
| X-Cube | ACL-43I | FDA UDI | Class I | Active |
| Td-Auto | CRB19NN | FDA UDI | Class I | Active |
| X-Cube | ACL(B)-01C | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #1 | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #11 | FDA UDI | Class II | Active |
| Ssg10 | SSG10 #4 | FDA UDI | Class II | Active |
| Traus Sus10 | TRAUS MBP10SX | FDA UDI | Class I | Active |
| X-Cube | ACL(B)-43I | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS TRT12NSH | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #3 | FDA UDI | Class I | Active |
| Traus Sus10 | TRAUS CRB26LX | FDA UDI | Class I | Active |
| Ssg10 | SSG10 #9 | FDA UDI | Class II | Active |
| X-Cube | AT-II | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #7 | FDA UDI | Class I | Active |
| Traus Ssg10 | TRAUS SSG10 #2 | FDA UDI | Class I | Active |
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