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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 K170549
Device Name TOKUYAMA CUREGRACE
Applicant
Tokuyama Dental Corporation
38-9 Taitou 1-Chome, Taitou-Ku
Tokyo,  JP 110-0016
Applicant Contact Fumio Takahashi
Correspondent
Fish & Richardson
1425 K St., NW, Suite 1100
Washington,  DC  20005
Correspondent Contact Keith Barritt
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
EBG  
Date Received02/24/2017
Decision Date 07/05/2017
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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