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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 K252035
Device Name DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
Applicant
Kamemizu Chemical Industry Co., Ltd.
17-16
Toyosato
Neyagawa,  JP 5720071
Applicant Contact Tomohiro Kinoshita
Correspondent
Kamemizu Chemical Industry Co., Ltd.
17-16
Toyosato
Neyagawa,  JP 5720071
Correspondent Contact Tomohiro Kinoshita
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/30/2025
Decision Date 09/17/2025
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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