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Yomi Robotic System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222049

by Neocis Inc

Identifiers

510(k) Number
K222049 FDA 510(k)
FDA Product Code
QRY 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)

Yomi Robotic System by Neocis Inc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neocis Inc
FDA Applicant
Neocis, Inc.

Sources (1)

  • FDA 510(k) K222049 24 fields · synced Jun 19, 2026