Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192197
Magicore II System · Innobiosurg Co., Ltd. · decided 2020-04-28 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| AMII IMPLANT | 454M5009S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08809986615732 |
| Short Abutment | MMAN6005 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039370806 |
| Magicore S | 502M4007S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800039334365 |
| Magicore S | 551M5008S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177316056 |
| Magic Abutment | MMF2N6503 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039389266 |
| Magic Abutment | MMPH4505 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039370905 |
| Magicore S | 552M6507S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800039336703 |
| Magicore S | 554M5009S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800039335621 |
| Magicore S | 453M4007S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800039333573 |
| Magicore S | 552MC6513S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177341256 |
| Magicore S | 552MC6512S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177341140 |
| Magicore S | 552MC6012S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177340372 |
| Magicore S | 454MC5007S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177332919 |
| Magicore S | 552M6008S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177317602 |
| Magic Abutment | MMF2H5004 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039388825 |
| AMII IMPLANT | 453M5007S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08809986615688 |
| Magicore S | 552MC6510S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177340921 |
| Magicore S | 553MC4512S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177338072 |
| Magicore S | 452MC4507S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800177332124 |
| Magic Abutment | MMG2H4502 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039389952 |
| Magic Abutment | MMFN6502 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039388658 |
| Short Abutment | MMAN6004 | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | NHA | 08800039370790 |
| Magicore S | 451M4509S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08800039334051 |
| AMII IMPLANT | 452M5009S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08809986615657 |
| AMII IMPLANT | 452M4013S | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) | DZE | 08809986615350 |