Yomi Robotic System
FDA 510(k)Class II (US FDA 510(k))
by Neocis Inc
Identifiers
- 510(k) Number
- K251835 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 Robotic System is a Dental Stereotaxic Instrument, classified as a class 2 device. It is used in dental procedures, providing robotic assistance for tasks such as dental implant surgery. The system is designed to provide accuracy and streamline the surgical experience.
The Yomi Robotic System is supplied as a single system, with a product code of PLV and regulation number 872.4120. It has been cleared by the FDA, with a clearance type of Traditional and a decision code of SESE. The system is intended for use in dental settings, with a medical specialty description of Dental.
Frequently asked questions
What is the Yomi Robotic System used for?
The Yomi Robotic System is used in dental procedures, such as dental implant surgery, to provide robotic assistance and accuracy.
How is the Yomi Robotic System supplied?
The Yomi Robotic System is supplied as a single system with a product code of PLV.
Is the Yomi Robotic System cleared by the FDA?
Yes, the Yomi Robotic System has been cleared by the FDA with a clearance type of Traditional and a decision code of SESE.
What medical specialty is the Yomi Robotic System intended for?
The Yomi Robotic System is intended for use in dental settings, with a medical specialty description of Dental.
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-Generation AI-Powered Robotic System for Dental ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251835 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocis Inc
- FDA Applicant
- Neocis, Inc.
Sources (1)
- FDA 510(k) K251835 24 fields · synced Sep 21, 2026