510(k) clearances

X-Guide Surgical Navigation System

X-Nav Technologies, LLC · Dental

K253954Substantially EquivalentTraditionalQRY
Open FDA's page for this record
Third party flag
N
City
Lansdale
Advisory committee description
Dental
Address 1
1555 Bustard Rd.
Address 2
Suite 75 & 110
Statement or summary
Summary
Product code
QRY
Zip code
19446
Applicant
X-Nav Technologies, LLC
Decision date
2026-08-28
Decision code
SESE
Country code
US
Device name
X-Guide Surgical Navigation System
Advisory committee
DE
Contact
Kimberly Chan
K number
K253954
State
PA
Date received
2025-12-10
Review advisory committee
DE
Postal code
19446
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Dental Navigation System
Medical specialty description
Dental
Regulation number
872.4120
Device class
2
Registration number
3014552222, 3011874573, 3011764595, 3012787974
FEI number
3014552222, 3011874573, 3011764595, 3012787974
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.