Cleared Traditional

K251835 - Yomi Robotic System (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251835 · Neocis, Inc. · Dental device
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Oct 2025
Decision
116d
Days
Class 2
Risk

K251835 is an FDA 510(k) clearance for the Yomi Robotic System. Classified as Dental Stereotaxic Instrument (product code PLV), Class II - Special Controls.

Submitted by Neocis, Inc. (Miami, US). The FDA issued a Cleared decision on October 10, 2025 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Neocis, Inc. devices

Submission Details

510(k) Number K251835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2025
Decision Date October 10, 2025
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLV Dental Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
Definition To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PLV Dental Stereotaxic Instrument

All 22
Devices cleared under the same product code (PLV) and FDA review panel - the closest regulatory comparables to K251835.
Yomi S Robotic System
K252376 · Neocis, Inc. · Oct 2025
Navident
K233563 · Claronav, Inc. · Jul 2024
Yomi Robotic System
K231018 · Neocis, Inc. · Aug 2023
Navident
K210947 · Claronav, Inc. · Jun 2022
Yomi Robotic System with YomiPlan Go
K211466 · Neocis, Inc. · Jun 2022
INLIANT Surgical Navigation System
K213392 · Navigate Surgical Technologies, Inc. · Feb 2022