NTO

Rinse, Oral, Antibacterial (By Physical Means)

产品代码

NTO

器械名称

Rinse, Oral, Antibacterial (By Physical Means)

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 872.5580

FDA 专业组

Dental

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

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

Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。