EMA
- 产品代码
- EMA
- 器械名称
- Cement, Dental
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 872.3275
- 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
- 11 份，可直接下载
- FDA 历史累计 510(k)
- 508 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 |
|---|---|---|---|---|
| K254201 | 2026-08-13 | Mediclus Co., Ltd. | Any-Cem | |
| K261937 | 2026-08-07 | The Belport Company Inc., DBA Gingi-Pa… | PacTemp Automix NE | |
| K261166 | 2026-07-09 | DiaDent Group International | DIA-CEM | |
| K254109 | 2026-05-18 | GC America, Inc. | G-CEM UNIVERSAL | FDA |
| K253337 | 2026-04-15 | Inter-Med, Inc. | REGEN Bioactive Cement | |
| K252606 | 2026-03-20 | Voco GmbH | Bifix Veneer LC, Bifix Veneer Try-In | — |
| K254063 | 2025-12-19 | Kulzer, LLC | iCEM Universal Plus | |
| K252785 | 2025-12-12 | Rizhao Huge Biomaterials Company, Ltd. | TopCEM Vigor SA Self-Adhesive Resin Cement | |
| K252808 | 2025-12-09 | Shofu Dental Corporation | GlasIonomer FX-LC | — |
| K252165 | 2025-10-28 | Shofu Dental Corporation | ZIRCONOMER P | — |
| K250953 | 2025-09-19 | GC America, Inc. | EQUIA LC ONE | |
| K251775 | 2025-09-02 | Belport Company, Inc., Gingi-Pak | RODIN Cement | — |
| K251470 | 2025-07-11 | Shofu Dental Corporation | ResiCem EX | — |
| K250156 | 2025-07-11 | Bisco, Inc. | Choice 2 DC | |
| K250566 | 2025-06-20 | Spident Co., Ltd. | EsCem RMGI | |
| K242366 | 2025-01-10 | Overfibers S.R.L. | OverCEM SA Universal; OverCEM SA Translucent; OverCE… | |
| K240714 | 2024-07-24 | Cosmedent, Inc. | Insure® Universal; Insure® Universal Automix | — |
| K241204 | 2024-06-28 | Rizhao Huge Biomaterials Company, Ltd. | TopCEM-Veneer Light Cure Veneer Cement | |
| K240888 | 2024-04-02 | Dentsply Sirona | Calibra Abutment Resin Cement | FDA |
| K233161 | 2023-09-28 | Shofu Dental Corporation | BeautiLink SA | — |
FDA 官方分类页： EMA
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。