NYE

Fixture Mount Kit

产品代码: NYE
器械名称: Fixture Mount Kit
管理类别: 第 1 类（Class I）
21 CFR 条款: 21 CFR 872.3980
FDA 专业组: Dental
上市路径: Enforcement Discretion

FDA 分类定义

Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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： NYE

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。