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510(k) K203401

Neocis Guidance System (NGS) with Patient Splints (EPS) by Neocis, Inc. — Product Code PLV

K203401 is an FDA 510(k) premarket notification submitted by Neocis, Inc. for the device "Neocis Guidance System (NGS) with Patient Splints (EPS)". The FDA issued a decision of Substantially Equivalent on December 15, 2020. The device falls under product code PLV (Dental Stereotaxic Instrument), a Class II device regulated under 21 CFR 872.4120. Neocis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2020
Date Received
November 19, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Stereotaxic Instrument
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

To facilitate dental implant placement in patients that are partially endentulous or edentulous.

Other clearances by Neocis, Inc.

  • K252376 — Yomi S Robotic System (October 28, 2025)
  • K251835 — Yomi Robotic System (October 10, 2025)
  • K231018 — Yomi Robotic System (August 14, 2023)
  • K222750 — Yomi Robotic System (December 8, 2022)
  • K222049 — Yomi Robotic System (November 4, 2022)
  • K211466 — Yomi Robotic System with YomiPlan Go (June 14, 2022)
  • K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (December 22, 2021)
  • K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array (July 28, 2021)
  • K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0 (December 4, 2020)
  • K202100 — Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (October 19, 2020)

Other clearances for product code PLV

  • K252376 — Yomi S Robotic System (October 28, 2025)
  • K251835 — Yomi Robotic System (October 10, 2025)
  • K233563 — Navident (July 25, 2024)
  • K231018 — Yomi Robotic System (August 14, 2023)
  • K210947 — Navident (June 27, 2022)
  • K211466 — Yomi Robotic System with YomiPlan Go (June 14, 2022)
  • K213392 — INLIANT Surgical Navigation System (February 22, 2022)
  • K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (December 22, 2021)
  • K211129 — Neocis Guidance System (NGS) with Intraoral Fiducial Array (July 28, 2021)
  • K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0 (December 4, 2020)

FDA data resources