NYH

Plaque Disclosing Kit

产品代码: NYH
器械名称: Plaque Disclosing Kit
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 872.1740
FDA 专业组: Dental
上市路径: Enforcement Discretion
FDA 历史累计 510(k): 1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

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： NYH

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。