QMJ
- 产品代码
- QMJ
- 器械名称
- Powered Radiofrequency Toothbrush
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 872.6866
- FDA 专业组
- Dental
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 2 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
FDA 官方分类页: QMJ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。