Medical device company profile

Neocis

Yomi robotic planning and guidance systems for dental implant surgery.

Medical Device ManufacturerDental & Oral HealthImplant DentistryCommercial-stage

Headquarters🇺🇸Miami, Florida, United States

Founded2009

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Disclosed fundingUS$20 million ^[36]Disclosed round · 2023

Official websitewww.neocis.com ↗

Company overview

Neocis develops Yomi, a robotic platform supporting dental implant planning and surgical guidance. The system combines preoperative software with haptic guidance of surgical instruments, keeping the clinician in control of the procedure.

The Miami-based company introduced its next-generation Yomi S system in November 2025 following an October 2025 FDA 510(k) clearance. The clearance is device-specific; future indications and features under development are separate from currently authorized workflows.

Co-founder Alon Mozes leads Neocis, with Brent Berthy serving as president. Commercial adoption depends on clinical training, integration into dental practice workflows and capital-equipment purchasing, alongside evidence supporting accuracy and procedural efficiency.

^{[31][33][34][35][36]}

Leadership

4 people

Alon MozesCEO & Co-Founder ^[35]

Brent BerthyPresident ^[35]

Juan SalcedoEngineering Fellow & Co-Founder ^[35]

Dennis MosesChief Technical Officer ^[35]

Products & regulatory status How does MedTechIndex get this information?

Summary

Yomi S has its own 510(k) decision, K252376. Earlier Yomi/Neocis Guidance System decisions document the platform’s evolution, including planning software and splint configurations; they should not all be counted as clearances of the current Yomi S model. ^{[33][31][19][35][1]}

The matched FDA history contains 3 distinct recall events: 0 open, 3 terminated. Z-0929-2021 (2020-10-30; terminated): The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. Z-2637-2020 (2020-05-14; terminated): The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. Z-0511-2020 (2019-10-04; terminated): The Fiducial Array may mismatch their measurement files resulting in failed landmark check. ^{[27][24][25][26][23]}

Regulatory snapshot How to read this snapshot

U.S. FDA

1
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Dental surgical robot

Yomi S Robotic System ↗

Next-generation robotic planning and guidance platform for dental implantation. ^[33][30]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Activity & Milestones

1 events

2025-11-17 · Commercialization

Yomi S introduced

Next-generation Yomi S robotic system introduced following 510(k) clearance. ^[31]

36 Cited Sources

Accessed 10/29/2026

[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[2] FDA K161399 — Neocis Guidance System ↗U.S. Food and Drug Administration · regulatory record

[3] FDA K173402 — Neocis Guidance System (NGS) with Chairside Splint ↗U.S. Food and Drug Administration · regulatory record

[4] FDA K182776 — Neocis Guidance System ↗U.S. Food and Drug Administration · regulatory record

[5] FDA K191363 — Neocis Planning Software Application (NPSA) for 3rd Party PCs ↗U.S. Food and Drug Administration · regulatory record

[6] FDA K191605 — Neocis Guidance System (NGS) ↗U.S. Food and Drug Administration · regulatory record

[7] FDA K200348 — Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) ↗U.S. Food and Drug Administration · regulatory record

[8] FDA K200805 — Neocis Guidance System (NGS) with Patient Splints ↗U.S. Food and Drug Administration · regulatory record

[9] FDA K202100 — Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) ↗U.S. Food and Drug Administration · regulatory record

[10] FDA K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0 ↗U.S. Food and Drug Administration · regulatory record

[11] FDA K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS) ↗U.S. Food and Drug Administration · regulatory record

[12] FDA K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1 ↗U.S. Food and Drug Administration · regulatory record

[13] FDA K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array ↗U.S. Food and Drug Administration · regulatory record

[14] FDA K211466 — Yomi Robotic System with YomiPlan Go ↗U.S. Food and Drug Administration · regulatory record

[15] FDA K222049 — Yomi Robotic System ↗U.S. Food and Drug Administration · regulatory record

[16] FDA K222750 — Yomi Robotic System ↗U.S. Food and Drug Administration · regulatory record

[17] FDA K231018 — Yomi Robotic System ↗U.S. Food and Drug Administration · regulatory record

[18] FDA K251835 — Yomi Robotic System ↗U.S. Food and Drug Administration · regulatory record

[19] FDA K252376 — Yomi S Robotic System ↗U.S. Food and Drug Administration · regulatory record

[20] FDA De Novo database — research search ↗FDA / openFDA · regulatory record

[21] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[22] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[23] FDA recall Z-0511-2020 — Neocis Inc. ↗U.S. Food and Drug Administration · regulatory record

[24] FDA recall Z-2637-2020 — Neocis Inc. ↗U.S. Food and Drug Administration · regulatory record

[25] FDA recall Z-2638-2020 — Neocis Inc. ↗U.S. Food and Drug Administration · regulatory record

[26] FDA recall Z-2639-2020 — Neocis Inc. ↗U.S. Food and Drug Administration · regulatory record

[27] FDA recall Z-0929-2021 — Neocis, Inc. ↗U.S. Food and Drug Administration · regulatory record

[28] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[29] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[30] FDA 510(k) K252376 ↗U.S. Food and Drug Administration · regulatory database

[31] Yomi S launch announcement ↗Neocis · company website

[32] Yomi Dental Robot - Next Gen Dental Implant Surgery - Neocis ↗Neocis · company website

[33] Company and Yomi platform ↗Neocis · company website

[34] Employer hiring source reviewed ↗Neocis · company website

[35] Current leadership ↗Neocis · company website

[36] Neocis announces US$20 million additional financing ↗Neocis · company announcement