NOF

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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.

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: 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。