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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 K885007
Device Name CIMPAT S TEMPORARY DENTAL CEMENT
Applicant
Specialites Septodont
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact S REICHERTZ
Correspondent
Specialites Septodont
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact S REICHERTZ
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/01/1988
Decision Date 03/01/1989
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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