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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 K990528
Device Name ORTHOPHOS 3/3 CEPH/3 DS
Applicant
Sirona Dental Systems GmbH
49 Plain St.
N. Attleboro,  MA  02760 -4153
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
Sirona Dental Systems GmbH
49 Plain St.
N. Attleboro,  MA  02760 -4153
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
EAG  
Date Received02/19/1999
Decision Date 04/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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