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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 K844846
Device Name ESPE KETAC-CEM RADIOPAQUE
Applicant
Espe GmbH (Us)
200 Lake Ave. (#205)
Lake Worth,  FL  33460
Applicant Contact HAROLD A OPOTOW
Correspondent
Espe GmbH (Us)
200 Lake Ave. (#205)
Lake Worth,  FL  33460
Correspondent Contact HAROLD A OPOTOW
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/13/1984
Decision Date 03/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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