NKJ

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

产品代码
NKJ
器械名称
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
管理类别
第 1 类(Class I)
21 CFR 条款
21 CFR 872.3540
FDA 专业组
Dental
上市路径
豁免 510(k)(仍须遵守通用控制与注册列名)

FDA 分类定义

OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.

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)。

FDA 官方分类页: NKJ
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。