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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 K073350
Device Name SCANORA 3D
Applicant
Soredex Palodex Group OY
Nahkelantie 160
Tuusula,  FI FIN-04300
Applicant Contact JOUNI ONNELA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
JAK  
Date Received11/29/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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