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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K070535
Device Name RETROPAN CCD-TWAIN-USB
Applicant
Video Dental Concepts, Inc.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32175
Applicant Contact Claude Berthoin
Correspondent
Video Dental Concepts, Inc.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32175
Correspondent Contact Claude Berthoin
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/26/2007
Decision Date 04/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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