Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)— 510(k) K200348

Name: FDA 510(k) clearance K200348
Creator: U.S. Food and Drug Administration
Published: 2020-05-08

Substantially Equivalent

Neocis, Inc.

FDA 510(k) clearance K200348 for Neocis Guidance System (NGS) with Fiducial Array Splint (FAS), Substantially Equivalent on 2020-05-08. 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: 2020-02-12
Decision date: 2020-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLV

view all

K252376 — Yomi S Robotic System2025-10-28
K251835 — Yomi Robotic System2025-10-10
K233563 — Navident2024-07-25
K231018 — Yomi Robotic System2023-08-14
K210947 — Navident2022-06-27

More clearances from Neocis, Inc.

view all

K222750 — Yomi Robotic System2022-12-08
K222049 — Yomi Robotic System2022-11-04
K211466 — Yomi Robotic System with YomiPlan Go2022-06-14
K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.12021-12-22
K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array2021-07-28

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