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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K002793
Device Name KETAC CEM U
Applicant
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact ANDREAS PETERMANN
Correspondent
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Correspondent Contact ANDREAS PETERMANN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/07/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
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