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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 K972276
Device Name CEREC 2 CROWN SOFTWARE
Applicant
Siemens AG
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact STEVEN CLARKE
Correspondent
Siemens AG
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact STEVEN CLARKE
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/18/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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