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Surgical devices · 21 CFR 872 Subpart E

Dental Stereotaxic Instrument

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

FDA codePLVClass221 CFR872.4120Pathway510(k)
Companies listing it
65 makers
Brands and models
17
510(k) clearances
238 in five years
FDA name
Dental Stereotaxic Instrument
2015: 12016: 22018: 22019: 22020: 72021: 22022: 32023: 12024: 12025: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list PLV

6 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
NeocisUnited StatesMakerYomi Robotic System · Yomi S Robotic System192026
X-NAV Technologies, LLC.United StatesMakerEDX Bone Screw · EDX Tracker Arm · IconiX · IconiX AI · +862026
ClaroNav Inc.CanadaMakerNavident32024
Navigate Surgical Technologies Inc.CanadaMakerINLIANT® Surgical Navigation System12022
Pacific Plastics Injection MoldingUnited StatesMaker———
Nobel Biocare Services AGSwitzerlandContract manufacturerX-guide942026

510(k) clearances

Decided510(k)DeviceApplicant
28 Oct 2025K252376Yomi S Robotic SystemNeocis
10 Oct 2025K251835Yomi Robotic SystemNeocis
25 Jul 2024K233563NavidentClaroNav Inc.
14 Aug 2023K231018Yomi Robotic SystemNeocis
27 Jun 2022K210947NavidentClaroNav Inc.
14 Jun 2022K211466Yomi Robotic System with YomiPlan GoNeocis
22 Feb 2022K213392INLIANT Surgical Navigation SystemNavigate Surgical Technologies Inc.
22 Dec 2021K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis
28 Jul 2021K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis
15 Dec 2020K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis
4 Dec 2020K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis
19 Oct 2020K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis
28 Jul 2020K200805Neocis Guidance System (NGS) with Patient SplintsNeocis
21 May 2020K200662X-Guide® Surgical Navigation SystemX-NAV Technologies, LLC.
8 May 2020K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis
3 Feb 2020K192579X-Guide Surgical Navigation SystemX-NAV Technologies, LLC.
2 Oct 2019K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis
11 Sep 2019K191605Neocis Guidance System (NGS)Neocis
21 Dec 2018K182776Neocis Guidance SystemNeocis
22 Feb 2018K173402Neocis Guidance System (NGS) with Chairside SplintNeocis
22 Dec 2016K161399Neocis Guidance SystemNeocis
8 Sep 2016K161406NavidentClaroNav Inc.
8 Oct 2015K150222X-Guide Surgical Navigation SystemX-NAV Technologies, LLC.

Official records: FDA product classification for PLV · 21 CFR 872.4120.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026