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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 K161406
Device Name Navident
Applicant
Claronav, Inc.
1140 Sheppard Ave. W.
Unit 10
Toronto,  CA M3K 2A2
Applicant Contact Doron Dekel
Correspondent
Claronav, Inc.
1140 Sheppard Ave. W.
Unit 10
Toronto,  CA M3K 2A2
Correspondent Contact Doron Dekel
Regulation Number872.4120
Classification Product Code
PLV  
Date Received05/20/2016
Decision Date 09/08/2016
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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