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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K990108
Device Name LC FLOWFILL
Applicant
S & C Polymer GmbH
Robert-Bosch-Str.5
Elmshorn,  DE D-25335
Applicant Contact JURGEN ENGELRECHT
Correspondent
S & C Polymer GmbH
Robert-Bosch-Str.5
Elmshorn,  DE D-25335
Correspondent Contact JURGEN ENGELRECHT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/13/1999
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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