The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ibs Implant System Ii.
| Device ID | K200753 |
| 510k Number | K200753 |
| Device Name: | IBS Implant System II |
| 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 | 2020-03-23 |
| Decision Date | 2020-06-09 |