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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 K994172
Device Name CEREC 3
Applicant
Sirona Dental Systems GmbH
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
Sirona Dental Systems GmbH
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/10/1999
Decision Date 02/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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