Kamemizu Chemical Industry Co., Ltd. · Class II · Cleared Sep 17, 2025
| 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. |
| Product code | EBI |
| Device class | Class II |
| Decision date | Sep 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3760 |
DENTURE SOFT EX is a soft acrylic resin lining material for removable dentures used for temporary relining, tissue conditioning, and obtaining functional impressions. It consists of a powder (acrylic polymer and additives) and liquid (plasticizer, ethanol, and others) that are mixed to form soft acrylic resin.
The predicate device consists of powder (mainly poly(ethyl methacrylate)) and liquid (mainly plasticizer benzyl benzoate and ethanol). The subject device uses the same composition and technical characteristics, with mixing of powder and liquid causing gelation and soft acrylic resin formation through the same mechanism.
Bench testing was performed in accordance with ISO 10139-1:2018. The subject device meets performance requirements of ISO 10139-1:2018.
The subject device has identical indications for use as the predicate (COE COMFORT). Both devices use the same powder and liquid composition with the same gelation mechanism. The subject device demonstrates equivalent performance to the predicate device under ISO 10139-1:2018 testing, establishing that it is as safe, effective, and performs as well as the predicate device.
View the full FDA submission: accessdata.fda.gov