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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K123494
Device Name SOLEA
Applicant
Convergent Dental, Inc.
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact Carrie Hetrick
Correspondent
Convergent Dental, Inc.
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/13/2012
Decision Date 02/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
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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