K233450
- 510(k) 号
- K233450
- 器械名称
- MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
- 申请人
- Megagen Implant Co., Ltd. KR
- 产品代码
- NHA — Abutment, Implant, Dental, Endosseous
- 批准日期
- 2024-01-22
- 受理日期
- 2023-10-20
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Dental
FDA 官方记录: K233450
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。