PLV · Class II · 21 CFR 872.4120

FDA Product Code PLV: Dental Stereotaxic Instrument

To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous.

Leading manufacturers include Neocis, Inc., X-Nav Technologies, LLC and Claronav, Inc..

23
Total
23
Cleared
156d
Avg days
2015
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 156d avg (recent)

FDA 510(k) Cleared Dental Stereotaxic Instrument Devices (Product Code PLV)

23 devices
1–23 of 23
Cleared Oct 28, 2025
Yomi S Robotic System
K252376
Neocis, Inc.
Dental · 90d
Cleared Oct 10, 2025
Yomi Robotic System
K251835
Neocis, Inc.
Dental · 116d
Cleared Jul 25, 2024
Navident
K233563
Claronav, Inc.
Dental · 262d
Cleared Aug 14, 2023
Yomi Robotic System
K231018
Neocis, Inc.
Dental · 126d
Cleared Jun 27, 2022
Navident
K210947
Claronav, Inc.
Dental · 454d
Cleared Jun 14, 2022
Yomi Robotic System with YomiPlan Go
K211466
Neocis, Inc.
Dental · 399d
Cleared Feb 22, 2022
INLIANT Surgical Navigation System
K213392
Navigate Surgical Technologies, Inc.
Dental · 130d
Cleared Dec 22, 2021
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
K210711
Neocis, Inc.
Dental · 287d
Cleared Jul 28, 2021
Neocis Guidance System (NGS) with Intraoral Fiducial Array
K211129
Neocis, Inc.
Dental · 103d
Cleared Dec 15, 2020
Neocis Guidance System (NGS) with Patient Splints (EPS)
K203401
Neocis, Inc.
Dental · 26d
Cleared Dec 04, 2020
Neocis Guidance System (NGS) with Yomi Plan v2.0
K202264
Neocis, Inc.
Dental · 115d
Cleared Oct 19, 2020
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
K202100
Neocis, Inc.
Dental · 82d
Cleared Jul 28, 2020
Neocis Guidance System (NGS) with Patient Splints
K200805
Neocis, Inc.
Dental · 123d
Cleared May 21, 2020
X-Guide® Surgical Navigation System
K200662
X-Nav Technologies, LLC
Dental · 69d
Cleared May 08, 2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
K200348
Neocis, Inc.
Dental · 86d
Cleared Feb 03, 2020
X-Guide Surgical Navigation System
K192579
X-Nav Technologies, LLC
Dental · 137d
Cleared Oct 02, 2019
Neocis Planning Software Application (NPSA) for 3rd Party PCs
K191363
Neocis, Inc.
Dental · 133d
Cleared Sep 11, 2019
Neocis Guidance System (NGS)
K191605
Neocis, Inc.
Dental · 86d
Cleared Dec 21, 2018
Neocis Guidance System
K182776
Neocis, Inc.
Dental · 81d
Cleared Feb 22, 2018
Neocis Guidance System (NGS) with Chairside Splint
K173402
Neocis, Inc.
Dental · 114d

About Product Code PLV - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code PLV since 2015, with 23 receiving FDA clearance (average review time: 156 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PLV Product Code

FDA review times for PLV submissions have been consistent, averaging 156 days recently vs 156 days historically.

PLV devices are reviewed by the Dental panel. Browse all Dental devices →