The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magicore Ii System.
| Device ID | K201621 |
| 510k Number | K201621 |
| Device Name: | Magicore II System |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2020-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039371674 | K201621 | 000 |
| 08800039371667 | K201621 | 000 |