Cleared Traditional

K222750 - Yomi Robotic System (FDA 510(k) Clearance)

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

K222750 · Neocis, Inc. · Dental device
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Dec 2022
Decision
87d
Days
Class 2
Risk

K222750 is an FDA 510(k) clearance for the Yomi 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 December 8, 2022 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neocis, Inc. devices

Submission Details

510(k) Number K222750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2022
Decision Date December 08, 2022
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.