Cleared Traditional

K261321 - Yomi S Robotic System

K261321 is an FDA 510(k) clearance for Yomi S Robotic System, manufactured by Neocis, Inc.. The device is a Class 2 Dental device with product code QRY cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K261321 · Neocis, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
174d
Days
Class 2
Risk

K261321 is an FDA 510(k) clearance for the Yomi S Robotic System. Classified as Dental Navigation System (product code QRY), Class II - Special Controls.

Submitted by Neocis, Inc. (Miami, US). The FDA issued a Cleared decision on October 13, 2026 after a review of 174 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K261321

510(k) Number K261321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2026
Decision Date October 13, 2026
Days to Decision 174 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
46d slower than avg
Panel avg: 128d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QRY Device Classification - Class 2, Special Controls

Product Code QRY Dental Navigation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
Definition Intended To Provide Real-time Guidance On The Orientation And Location Of The Dental Instrument Relative To The Patient's Anatomy For General Dentistry Procedures.
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 - QRY Dental Navigation System

Devices cleared under the same product code (QRY) and FDA review panel - the closest regulatory comparables to K261321.
X-Guide Surgical Navigation System
K253954 · X-Nav Technologies, LLC · Aug 2026
X-Guide Surgical Navigation System
K232148 · X-Nav Technologies, LLC · Feb 2024
Yomi Robotic System
K222750 · Neocis, Inc. · Dec 2022
Yomi Robotic System
K222049 · Neocis, Inc. · Nov 2022
X-Guide® Surgical Navigation System
K211701 · X-Nav Technologies, LLC · Feb 2022
K261321 · Yomi S Robotic System
Download PDF FDA Summary Neocis, Inc.