NOF
- 产品代码
- NOF
- 器械名称
- System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 872.3661
- 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 历史累计 510(k)
- 5 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.
FDA 官方分类页: NOF
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。