MQC
- 产品代码
- MQC
- 器械名称
- Mouthguard, Prescription
- 管理类别
- 第 U 类（Unclassified）
- FDA 专业组
- Unknown
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 17 件
- 其中 Summary 已存档
- 13 份，可直接下载
- FDA 历史累计 510(k)
- 71 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)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253798 | 2026-03-02 | Guangzhou Heygears IMC., Inc. | UltraPrint-Dental Hard Splint UV | |
| K250743 | 2025-12-05 | Remvia | Remvia NightGuard | |
| K251252 | 2025-08-01 | Shandong Huge Dental Material Corporat | NOBILCAM IMPAK Disc | |
| K241729 | 2025-03-18 | Whip Mix Corporation | Hard Splint & Thermo-Adaptive Splint | |
| K243516 | 2025-02-10 | Grindguard, Inc. | Remi Custom Night Guard | |
| K241369 | 2024-08-22 | Lijia, LLC | LIJIA Night Guard | |
| K231775 | 2024-08-08 | Pro3Dure Medical | GR Resin System MSI | |
| K241311 | 2024-08-02 | Bernhard Förster GmbH | Thermoforming Sheet Materials (Track A); Thermoformi | |
| K240463 | 2024-06-04 | Slow Wave, Inc. | Slow Wave DS8 (SWDS802) | |
| K231793 | 2024-03-26 | Belport Company, Inc., Gingi-Pak | RODIN 3D Resin SPLINT, Hard/Flex | — |
| K232087 | 2024-02-16 | Formlabs Ohio, Inc. | Dental LT Comfort Resin | FDA |
| K230548 | 2024-02-02 | Myohealth Technologies, LLC | Myoaligner Appliance | |
| K230592 | 2024-01-18 | LuxCreo, Inc. | LuxCreo Dental Night Guard Resin | — |
| K222845 | 2023-11-28 | Frey Oral Technologies, LLC | Clench Relief Mouth Piece PRO RX, Clench Relief Mout | |
| K230495 | 2023-10-13 | Meris Investment Group | Serena Sleep Night Guard | |
| K232448 | 2023-10-12 | Detax GmbH | FREEPRINT® splintmaster | |
| K230237 | 2023-09-14 | Hkable 3D Biologic Printing Technology | Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.6 | — |
FDA 官方分类页： MQC
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。