The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magicore System.
| Device ID | K201981 |
| 510k Number | K201981 |
| Device Name: | Magicore System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Bo-yeon Lim |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-16 |
| Decision Date | 2020-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039393621 | K201981 | 000 |
| 08800090659919 | K201981 | 000 |
| 08800090659902 | K201981 | 000 |
| 08800090659896 | K201981 | 000 |
| 08800090659889 | K201981 | 000 |
| 08800039355162 | K201981 | 000 |
| 08800039355155 | K201981 | 000 |
| 08800039355148 | K201981 | 000 |
| 08800039355131 | K201981 | 000 |
| 08800039315555 | K201981 | 000 |
| 08800039315548 | K201981 | 000 |
| 08800039315531 | K201981 | 000 |
| 08800039315524 | K201981 | 000 |
| 08800039315517 | K201981 | 000 |
| 08800039315500 | K201981 | 000 |
| 08800039315494 | K201981 | 000 |
| 08800039315487 | K201981 | 000 |
| 08800039315401 | K201981 | 000 |
| 08800039315418 | K201981 | 000 |
| 08800039393614 | K201981 | 000 |
| 08800039393607 | K201981 | 000 |
| 08800039393591 | K201981 | 000 |
| 08800039354943 | K201981 | 000 |
| 08800039354936 | K201981 | 000 |
| 08800039354929 | K201981 | 000 |
| 08800039354912 | K201981 | 000 |
| 08800039354721 | K201981 | 000 |
| 08800039354714 | K201981 | 000 |
| 08800039354707 | K201981 | 000 |
| 08800039354691 | K201981 | 000 |
| 08800039315463 | K201981 | 000 |
| 08800039315456 | K201981 | 000 |
| 08800039315449 | K201981 | 000 |
| 08800039315432 | K201981 | 000 |
| 08800039315425 | K201981 | 000 |
| 08800039315470 | K201981 | 000 |