NPZ
- 产品代码
- NPZ
- 器械名称
- Bone Grafting Material, Dental, With Biologic Component
- 管理类别
- 第 3 类(Class III)
- 21 CFR 条款
- 21 CFR 872.3930
- FDA 专业组
- Dental
- 上市路径
- 需 PMA 上市前批准
- 标记
- 属植入器械
FDA 分类定义
Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.
FDA 官方分类页: NPZ
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。