K252035

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)

510(k) 号
K252035
器械名称
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)
申请人
Kamemizu Chemical Industry Co., Ltd. JP
产品代码
EBI — Resin, Denture, Relining, Repairing, Rebasing
批准日期
2025-09-17
受理日期
2025-06-30
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
Dental
PDF下载 510(k) Summary本站存档 · 0.4 MB · FDA 公有领域文件

也可从 FDA 官方下载: K252035.pdf

FDA 官方记录: K252035
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。