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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K982537
Device Name TOKUYAMA SOFRELINER
Applicant
Tokuyama America, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Tokuyama America, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3760
Classification Product Code
EBI  
Date Received07/21/1998
Decision Date 08/24/1998
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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