Cleared Special

X-Guide® Surgical Navigation System (K200662) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200662 · X-Nav Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
69d
Days
Class 2
Risk

K200662 is an FDA 510(k) clearance for the X-Guide® Surgical Navigation System. Classified as Dental Stereotaxic Instrument (product code PLV), Class II - Special Controls.

Submitted by X-Nav Technologies, LLC (Lansdale, US). The FDA issued a Cleared decision on May 21, 2020 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all X-Nav Technologies, LLC devices

Submission Details

510(k) Number K200662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2020
Decision Date May 21, 2020
Days to Decision 69 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PLV Dental Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
Definition To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PLV Dental Stereotaxic Instrument

All 19
Devices cleared under the same product code (PLV) and FDA review panel - the closest regulatory comparables to K200662.
Neocis Guidance System (NGS) with Yomi Plan v2.0
K202264 · Neocis, Inc. · Dec 2020
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
K202100 · Neocis, Inc. · Oct 2020
Neocis Guidance System (NGS) with Patient Splints
K200805 · Neocis, Inc. · Jul 2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
K200348 · Neocis, Inc. · May 2020
X-Guide Surgical Navigation System
K192579 · X-Nav Technologies, LLC · Feb 2020
Neocis Planning Software Application (NPSA) for 3rd Party PCs
K191363 · Neocis, Inc. · Oct 2019