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510(k) K211466

Yomi Robotic System with YomiPlan Go by Neocis, Inc. — Product Code PLV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2022
Date Received
May 11, 2021
Clearance Type
Traditional
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)
  • 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)
  • K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS) (December 15, 2020)
  • 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)
  • 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)
  • K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS) (December 15, 2020)
  • K202264 — Neocis Guidance System (NGS) with Yomi Plan v2.0 (December 4, 2020)