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)

About This 510(k) Submission

K252035 is an FDA 510(k) clearance for the 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), a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Kamemizu Chemical Industry Co., Ltd. (Neyagawa, JP). The FDA issued a Cleared decision on September 17, 2025, 79 days after receiving the submission on June 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.