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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 K941452
Device Name ULTRACAM II
Applicant
Dental Vision Direct, Inc.
11661 San Vicente Blvd.
Suite 414
Los Angeles,  CA  90049
Applicant Contact W. EDWARD JOHANSEN
Correspondent
Dental Vision Direct, Inc.
11661 San Vicente Blvd.
Suite 414
Los Angeles,  CA  90049
Correspondent Contact W. EDWARD JOHANSEN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/24/1994
Decision Date 06/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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