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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 K083344
Device Name HELIODENT PLUS
Applicant
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE D-64625
Applicant Contact FRITZ KOLLE
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received11/13/2008
Decision Date 12/23/2008
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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