FDA.reportPublic FDA data

510(k) K252376

Device
Yomi S Robotic System
Applicant
Neocis, Inc.
510(k) number
K252376
Product code
PLV
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-28
Date received
2025-07-30
Regulation
872.4120
Classification name
Dental Stereotaxic Instrument
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jorge Fernandes
Address
545 NW 26th St. Suite 700 Miami FL US 33127 33127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251835Yomi Robotic SystemNeocis, Inc.2025-10-10
K233563NavidentClaronav, Inc.2024-07-25
K231018Yomi Robotic SystemNeocis, Inc.2023-08-14
K210947NavidentClaronav, Inc.2022-06-27
K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.2022-06-14
K213392INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc.2022-02-22
K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc.2021-12-22
K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc.2021-07-28
K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc.2020-12-15
K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc.2020-12-04
K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis, Inc.2020-10-19
K200805Neocis Guidance System (NGS) with Patient SplintsNeocis, Inc.2020-07-28
K200662X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC2020-05-21
K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis, Inc.2020-05-08
K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2020-02-03