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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K092583
Device Name SOPROLIFE
Applicant
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact RICK ROSATI
Regulation Number872.1745
Classification Product Code
NBL  
Date Received08/21/2009
Decision Date 01/13/2010
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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