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510(k) K222049

Yomi Robotic System by Neocis, Inc. — Product Code QRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2022
Date Received
July 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Navigation System
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.

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)
  • 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)
  • 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 QRY

  • K232148 — X-Guide Surgical Navigation System (February 21, 2024)
  • K222750 — Yomi Robotic System (December 8, 2022)
  • K211701 — X-Guide® Surgical Navigation System (February 1, 2022)