Home / Device Classification / PLV

PLV — Dental Stereotaxic Instrument Class II

FDA Device Classification

Classification Details

Product Code
PLV
Device Class
Class II
Regulation Number
872.4120
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

To facilitate dental implant placement in patients that are partially endentulous or edentulous.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252376neocisYomi S Robotic SystemOctober 28, 2025
K251835neocisYomi Robotic SystemOctober 10, 2025
K233563claronavNavidentJuly 25, 2024
K231018neocisYomi Robotic SystemAugust 14, 2023
K210947claronavNavidentJune 27, 2022
K211466neocisYomi Robotic System with YomiPlan GoJune 14, 2022
K213392navigate surgical technologiesINLIANT Surgical Navigation SystemFebruary 22, 2022
K210711neocisNeocis Guidance System (NGS) with Yomi Plan v2.0.1December 22, 2021
K211129neocisNeocis Guidance System (NGS) with Intraoral Fiducial ArrayJuly 28, 2021
K203401neocisNeocis Guidance System (NGS) with Patient Splints (EPS)December 15, 2020
K202264neocisNeocis Guidance System (NGS) with Yomi Plan v2.0December 4, 2020
K202100neocisNeocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)October 19, 2020
K200805neocisNeocis Guidance System (NGS) with Patient SplintsJuly 28, 2020
K200662x-nav technologiesX-Guide® Surgical Navigation SystemMay 21, 2020
K200348neocisNeocis Guidance System (NGS) with Fiducial Array Splint (FAS)May 8, 2020
K192579x-nav technologiesX-Guide Surgical Navigation SystemFebruary 3, 2020
K191363neocisNeocis Planning Software Application (NPSA) for 3rd Party PCsOctober 2, 2019
K191605neocisNeocis Guidance System (NGS)September 11, 2019
K182776neocisNeocis Guidance SystemDecember 21, 2018
K173402neocisNeocis Guidance System (NGS) with Chairside SplintFebruary 22, 2018