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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 K020957
Device Name ORACAM
Applicant
Video Dental Concepts, Inc.
110 E. Granada Blvd.
Suite 208; P.O. Box 36
Ormond Beach,  FL  32175 -0036
Applicant Contact CLAUDE D BERTHOIN
Correspondent
Video Dental Concepts, Inc.
110 E. Granada Blvd.
Suite 208; P.O. Box 36
Ormond Beach,  FL  32175 -0036
Correspondent Contact CLAUDE D BERTHOIN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/25/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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