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Sign in to claim this brandOSADA ELECTRIC CO., LTD.
US
Last updated May 23, 2026
What OSADA ELECTRIC CO., LTD. makes
OSADA Electric Co., Ltd. manufactures dental and surgical handpieces, including ultrasonic tips for endodontic and periodontal scaling/debridement, remotely-driven dental power tools, and line-powered drilling/sawing systems. Their portfolio also includes endodontic apex locators, diamond files, micromotors, and drive cables for surgical/dental applications. Specific devices range from ultrasonic handpiece attachments like the Golz tip set to corded micromotors such as the L12M and pediatric ultrasonic systems like the OSADA PEDO-30W.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with submissions recorded in the FDA’s 510(k) and UDI registries. These products are intended for use in dental and surgical procedures, adhering to regulatory requirements for medical devices in the United States. The manufacturer is based in the US.
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 OSADA Electric Co., Ltd. primarily manufacture?
OSADA Electric Co., Ltd. specializes in dental and surgical handpieces, including ultrasonic tips for endodontic and periodontal procedures like scaling and debridement. Their portfolio also covers remotely-driven dental power tools, line-powered drilling and sawing systems, endodontic apex locators, diamond files, micromotors, and drive cables. These devices are designed for precision applications in dental and surgical settings, such as the OSADA PEDO-30W for pediatric use or the L12M micromotor for controlled drilling.
Where is OSADA Electric Co., Ltd. based, and how does this affect its regulatory compliance?
OSADA Electric Co., Ltd. is based in the United States, which means its devices must comply with FDA regulations. The company’s products are listed in the FDA’s 510(k) and UDI registries, indicating they undergo premarket submissions and unique device identification processes. This ensures traceability and adherence to U.S. medical device standards, though compliance is tied to individual devices, not the company itself.
Which regulatory registries list OSADA Electric Co., Ltd.’s devices, and why?
OSADA Electric Co., Ltd.’s devices appear in the FDA’s 510(k) and UDI registries. The 510(k) pathway is used for devices deemed substantially equivalent to existing approved products, requiring premarket notifications. The UDI system assigns unique identifiers to devices for tracking and regulatory purposes, ensuring transparency in the supply chain and compliance with FDA requirements for medical device traceability.
How are OSADA Electric Co., Ltd.’s devices classified under FDA regulations?
OSADA Electric Co., Ltd.’s devices fall into three FDA classification categories: Class I (generally low-risk, like some handpiece tips), Class II (moderate-risk, such as powered dental tools requiring special controls), and Unclassified (U), which may include experimental or emerging technologies pending final classification. The classification determines the regulatory pathway, with Class II devices often requiring additional validation before market entry.
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
- 690713813
Catalogue (175)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| St71 | ST71 | FDA UDI | Class II | Active |
| St42a | ST42A | FDA UDI | Class II | Active |
| Osada Exl-Osi2 | EXL-OSI2 | FDA UDI | Class I | Active |
| Lip Clip | Lip Clip | FDA UDI | U | Active |
| SE-03 handpiece | SE-03 | FDA UDI | Class II | Active |
| St24 | ST24 | FDA UDI | Class II | Active |
| St96 | ST96 | FDA UDI | Class II | Active |
| SC point 6 | SC point 6 | FDA UDI | Class II | Active |
| Diamond file C | Diamond file C | FDA UDI | Class II | Active |
| SC point 3 | SC point 3 | FDA UDI | Class II | Active |
| Pch-1 | PCH-1 | FDA UDI | Class I | Active |
| St33 | ST33 | FDA UDI | Class II | Active |
| SC point 4-19 | SC point 4-19 | FDA UDI | Class II | Active |
| SC point 2 | SC point 2 | FDA UDI | Class II | Active |
| SE-10 handpiece | SE-10 | FDA UDI | Class II | Active |
| St74 | ST74 | FDA UDI | Class II | Active |
| CH11B contra head | CH11B | FDA UDI | Class I | Active |
| Sh28 | SH28 | FDA UDI | Class I | Active |
| MC12 motorcord | MC12 | FDA UDI | Class I | Active |
| Sh41 | SH41 | FDA UDI | Class I | Active |
| CS10 contra shank | CS10 | FDA UDI | Class I | Active |
| St86 | ST86 | FDA UDI | Class II | Active |
| Osada Endex | K904742 | FDA 510(k) | U | Active |
| Add Line Devices(parts) Electric Handpiece Systems | K935443 | FDA 510(k) | Class II | Active |
| Osada Enac | K844250 | 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.
- Osada Electric Co., Ltd. SHINAGAWA-KU Tokyo · JP FEI 2832