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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K061175
Device Name CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
Applicant
Sota Precision Optics, Inc.
845 Aronson Lake Court
Roswell,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
Sota Precision Optics, Inc.
845 Aronson Lake Court
Roswell,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/27/2006
Decision Date 05/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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