NPL
- 产品代码
- NPL
- 器械名称
- Barrier, Animal Source, Intraoral
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 872.3930
- 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)
- 9 件
- 其中 Summary 已存档
- 9 份,可直接下载
- FDA 历史累计 510(k)
- 57 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
该代码近三年的 510(k)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K242817 | 2025-12-12 | Botiss Biomaterials GmbH | Jason membrane | |
| K250512 | 2025-12-05 | Neo Modulus (Suzhou) Medical Sci-Tech | Augmented Gingival Matrix | |
| K252253 | 2025-11-25 | Geistlich Pharma AG | Geistlich Mucograft® /Geistlich Mucograft® Seal; Ge | |
| K251062 | 2025-08-14 | Geistlich Pharma AG | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geist | |
| K250833 | 2025-04-15 | Geistlich Pharma AG | SwissMembrane X; SwissMembrane X Socket | |
| K233203 | 2024-05-01 | Collagen Matrix, Inc. | Soft Tissue Augmentation Resorbable Matrix | |
| K231513 | 2024-02-16 | Beijing Biosis Healing Biolog Ical Tec | Oral Matrix | |
| K231305 | 2024-01-23 | Aroa Biosurgery , Ltd. | Endoform Dental Membrane | |
| K230091 | 2023-10-06 | Purgo Biologics, Inc. | THE Cover |
FDA 官方分类页: NPL
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。