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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 K994285
Device Name ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
Applicant
Dentsply Intl.
901 W Oakton St.
Des Plaines,  IL  60018 -1884
Applicant Contact WILLIAM T COUSINS
Correspondent
Dentsply Intl.
901 W Oakton St.
Des Plaines,  IL  60018 -1884
Correspondent Contact WILLIAM T COUSINS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/20/1999
Decision Date 03/14/2000
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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