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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 K211701
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 Received06/03/2021
Decision Date 02/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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