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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Stereotaxic Instrument
510(k) Number K210947
Device Name Navident
Applicant
ClaroNav Inc
1140 Sheppard Avenue West Unit 10
Toronto,  CA M3K 2A2
Applicant Contact Tal Bresler Stramer
Correspondent
ClaroNav Inc
1140 Sheppard Avenue West Unit 10
Toronto,  CA M3K 2A2
Correspondent Contact Carly Desmond
Regulation Number872.4120
Classification Product Code
PLV  
Date Received03/30/2021
Decision Date 06/27/2022
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
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