Yomi S Robotic System
FDA 510(k)Class II (US FDA 510(k))
by Neocis Inc
Identifiers
- 510(k) Number
- K252376 FDA 510(k)
- FDA Product Code
- PLV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Yomi S Robotic System is a Dental Stereotaxic Instrument, classified as a Class II medical device under FDA regulations. It is designed to assist in precise dental implant placement by integrating robotic guidance with surgical procedures, enhancing accuracy and reproducibility in dental interventions. This system is intended for use in dental settings where stereotactic guidance is required to improve procedural outcomes.
The Yomi S Robotic System is supplied as a reusable medical device and is intended for use in controlled clinical environments such as dental clinics or oral surgery centers. It is not sterile at the time of shipment but is designed to be processed and prepared for use according to standard sterilization protocols. The system adheres to FDA clearance under 510K and is regulated under 21 CFR 872.4120, with a product code of PLV. Its robotic components are engineered for MRI safety compatibility where applicable, though specific MRI safety information should be verified per manufacturer guidelines.
Frequently asked questions
What is the Yomi S Robotic System primarily used for in a clinical setting?
The Yomi S Robotic System is designed to assist dental professionals in precise dental implant placement by providing robotic stereotactic guidance. This enhances accuracy and reproducibility during surgical procedures, making it particularly useful in dental clinics or oral surgery centers where guided implantology is required.
Is the Yomi S Robotic System intended for single-use or reusable applications?
The Yomi S Robotic System is explicitly labeled as a reusable medical device. It is not supplied sterile at the time of shipment and must be processed and sterilized according to standard protocols before use in controlled clinical environments.
How is the Yomi S Robotic System regulated by the FDA, and what does this mean for its use?
The Yomi S Robotic System holds FDA clearance under a 510K submission (K252376) and is classified as a Class II medical device under 21 CFR 872.4120 with the product code PLV. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in dental stereotactic procedures, adhering to established standards for robotic-assisted dental instruments.
Does the Yomi S Robotic System have any special considerations for MRI compatibility?
The robotic components of the Yomi S Robotic System are engineered with MRI safety compatibility in mind. However, specific MRI safety information should always be verified per the manufacturer’s guidelines, as compatibility may depend on the model and settings of the MRI machine being used.
What kind of clinical environments is the Yomi S Robotic System intended for?
The Yomi S Robotic System is designed for use in controlled clinical environments such as dental clinics or oral surgery centers. Its robotic guidance system is tailored for procedures requiring high precision, particularly in dental implantology, where accuracy and reproducibility are critical.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Homepage - Neocis, Robot-Guided Dental Implant Surgery - See The Yomi Robot - Yomi By Neocis, Neocis unveils next-gen AI-powered dental robot
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252376 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocis Inc
- FDA Applicant
- Neocis, Inc.
Sources (1)
- FDA 510(k) K252376 24 fields · synced Sep 20, 2026