K253681

TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

510(k) 号: K253681
器械名称: TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
申请人: Graphy, Inc. KR
产品代码: EBI — Resin, Denture, Relining, Repairing, Rebasing
批准日期: 2025-11-21
受理日期: 2025-11-21
决定: Substantially Equivalent
审查途径: Traditional
标记: 第三方审查
咨询委员会: Dental

PDF下载 510(k) Summary本站存档 · 12.2 MB · FDA 公有领域文件

也可从 FDA 官方下载： K253681.pdf

FDA 官方记录： K253681

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。