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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Navigation System
510(k) Number K232148
Device Name X-Guide Surgical Navigation System
Applicant
X-Nav Technologies, LLC
1555 Bustard Road
Suite 75
Lansdale,  PA  19446
Applicant Contact Kimberly Chan
Correspondent
X-Nav Technologies, LLC
1555 Bustard Road
Suite 75
Lansdale,  PA  19446
Correspondent Contact Kimberly Chan
Regulation Number872.4120
Classification Product Code
QRY  
Subsequent Product Code
PLV  
Date Received07/19/2023
Decision Date 02/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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