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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 K190940
Device Name Tokuyama Rebase III
Applicant
Tokuyama Dental Corporation
38-9 Taitou 1-Chome, Taitou-Ku
Tokyo,  JP 110-0016
Applicant Contact Keith A. Barritt
Correspondent
Fish & Richardson, P.C.
1001 Maine Ave., SW, Suite 1000
Washington,  DC  20024
Correspondent Contact Keith A. Barritt
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/10/2019
Decision Date 10/04/2019
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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