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510(k) K213392

INLIANT Surgical Navigation System by Navigate Surgical Technologies, Inc. — Product Code PLV

K213392 is an FDA 510(k) premarket notification submitted by Navigate Surgical Technologies, Inc. for the device "INLIANT Surgical Navigation System". The FDA issued a decision of Substantially Equivalent on February 22, 2022. The device falls under product code PLV (Dental Stereotaxic Instrument), a Class II device regulated under 21 CFR 872.4120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2022
Date Received
October 15, 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 for product code PLV

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  • 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)
  • 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)

FDA data resources