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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 K030663
Device Name TOKUYAMA SOFRELINER TOUGH
Applicant
Tokuyama Dental Corporation
2000 M St., NW 7th Floor
Washington,  DC  20036 -3307
Applicant Contact DANIEL J MANELLI
Correspondent
Tokuyama Dental Corporation
2000 M St., NW 7th Floor
Washington,  DC  20036 -3307
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3760
Classification Product Code
EBI  
Date Received03/03/2003
Decision Date 05/29/2003
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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