Cleared Traditional

K211701 - X-Guide® Surgical Navigation System (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211701 · X-Nav Technologies, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2022
Decision
243d
Days
Class 2
Risk

K211701 is an FDA 510(k) clearance for the X-Guide® Surgical Navigation System. Classified as Dental Navigation System (product code QRY), Class II - Special Controls.

Submitted by X-Nav Technologies, LLC (Lansdale, US). The FDA issued a Cleared decision on February 1, 2022 after a review of 243 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all X-Nav Technologies, LLC devices

Submission Details

510(k) Number K211701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2021
Decision Date February 01, 2022
Days to Decision 243 days
Submission Type Traditional
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
116d slower than avg
Panel avg: 127d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRY Dental Navigation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
Definition Intended To Provide Real-time Guidance On The Orientation And Location Of The Dental Instrument Relative To The Patient's Anatomy For General Dentistry Procedures.
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.