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
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 103d recently vs 161d historically

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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - PLV Product Code

Recent submissions under PLV have taken an average of 103 days to reach a decision - down from 161 days historically, suggesting improved FDA processing for this classification.

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