Yomi Robotic System— 510(k) K251835

Substantially Equivalent

Neocis, Inc.

FDA 510(k) clearance K251835 for Yomi Robotic System, Substantially Equivalent on 2025-10-10. Applicant: Neocis, Inc.. Device class: 2.

Clearance details

Applicant: Neocis, Inc.
Product code: Code PLV
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2025-06-16
Decision date: 2025-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLV

K252376 — Yomi S Robotic System2025-10-28
K233563 — Navident2024-07-25
K231018 — Yomi Robotic System2023-08-14
K210947 — Navident2022-06-27
K211466 — Yomi Robotic System with YomiPlan Go2022-06-14

More clearances from Neocis, Inc.

K222750 — Yomi Robotic System2022-12-08
K222049 — Yomi Robotic System2022-11-04
K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.12021-12-22
K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array2021-07-28
K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS)2020-12-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.