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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K060640
Device Name DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
Applicant
Dentamerica
18320 Bedford Circle
P.O. Box 3200
Industry,  CA  91744
Applicant Contact ERIC HUANG
Correspondent
Dentamerica
18320 Bedford Circle
P.O. Box 3200
Industry,  CA  91744
Correspondent Contact ERIC HUANG
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/10/2006
Decision Date 04/24/2006
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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