PNP
- 产品代码
- PNP
- 器械名称
- Dental Abutment Design Software For Dental Laboratory
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 872.3630
- FDA 专业组
- Dental
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 2 件
- 其中 Summary 已存档
- 2 份,可直接下载
- FDA 历史累计 510(k)
- 8 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
该代码近三年的 510(k)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K233252 | 2024-12-26 | Institut Straumann AG | Straumann CARES Visual and Nova Dental CAD | |
| K231529 | 2024-03-14 | Prismatik Dentalcraft, Inc. | CloudPoint FastDesign Chairside |
FDA 官方分类页: PNP
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。