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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K080882
Device Name CEREC OPTI SPRAY
Applicant
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE D-64625
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/31/2008
Decision Date 04/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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