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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 K843566
Device Name KETAC-SILVER
Applicant
Espe GmbH (Us)
104 S. Central Ave.
Valley Stream,  NY  11580
Applicant Contact HAROLD A OPOTOW
Correspondent
Espe GmbH (Us)
104 S. Central Ave.
Valley Stream,  NY  11580
Correspondent Contact HAROLD A OPOTOW
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/10/1984
Decision Date 12/06/1984
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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