KIF
- 产品代码
- KIF
- 器械名称
- Resin, Root Canal Filling
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 872.3820
- FDA 专业组
- Dental
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 20 件
- 其中 Summary 已存档
- 15 份,可直接下载
- FDA 历史累计 510(k)
- 145 件(全部年份;本站只收录近三年的明细)
该代码近三年的 510(k)(20 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261514 | 2026-08-25 | Guilin Kevin Peter Technology Co., Ltd… | Calcium Hydroxide Temporary Filling Material (KP-Cal… | |
| K261415 | 2026-06-29 | Guilin Kevin Peter Technology Co., Ltd… | Injectable Root Canal Sealer (KP-Root SP) | |
| K253167 | 2026-01-12 | Mediclus Co., Ltd. | Any-Paste | |
| K252890 | 2026-01-07 | Kerr Corporation | ZenSeal Pro | |
| K251465 | 2025-09-25 | Enpuno Biotechnology Co., Ltd. | Root canal repair materials (nRoot BP) | |
| K252285 | 2025-09-19 | Vericom Co., Ltd. | Well-Root PT | |
| K251884 | 2025-08-22 | Mediclus Co., Ltd. | One-Fil Putty Injectable | |
| K251390 | 2025-07-03 | Voco GmbH | MTA vpt | — |
| K250710 | 2025-06-11 | Enpuno Co., Ltd. | Injectable Root Canal Bioceramic Sealer (nRoot SP) | FDA |
| K243353 | 2025-03-14 | Mediclus Co., Ltd. | One-Fil Putty | |
| K243546 | 2025-02-13 | Dentsply Sirona, Inc. | AH Plus Endodontic Sealer | |
| K242934 | 2024-12-12 | Longly Biotechnology (Wuhan) Co., Ltd. | Bioceramic Root Canal Sealer and Repair Materials (i… | |
| K242702 | 2024-11-07 | Spident Co., Ltd. | VioSeal | |
| K241977 | 2024-10-03 | Longly Biotechnology (Wuhan) Co., Ltd. | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | FDA |
| K241457 | 2024-08-28 | Inter-Med, Inc. | Vista BC Putty | FDA |
| K240446 | 2024-07-30 | Shiva Products | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSe… | FDA |
| K240304 | 2024-05-28 | Enpuno Biotechnology Co., Ltd. | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, … | |
| K240365 | 2024-05-10 | Beijing C-Root Dental Medical Devices … | Bioceramic Root Repair Material (C-Root BP) | |
| K232182 | 2024-01-26 | Mediclus Co., Ltd. | One-Fil | |
| K232299 | 2023-09-29 | Meta Biomed Co., Ltd. | CeraPutty |
FDA 官方分类页: KIF
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。